Recruiting
Phase 1

MEB-1170

Sponsor:

Mebias Discovery, Inc

Code:

NCT05748119

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

MEB-1170

Placebo

Study Details

Brief summary:

Primary Objective: To determine the safety and tolerability of single and multiple ascending oral doses of MEB-1170 in healthy subjects.

Secondary Objectives:

1. To determine the single and multiple oral dose pharmacokinetic profiles of MEB-1170 and the primary metabolite, M373, in healthy subjects.
2. To determine the effect of food on the pharmacokinetic (PK) profile of a single oral dose of MEB-1170 in healthy subjects.
3. To assess the pharmacodynamic (PD) response following single and multiple oral doses of MEB-1170

Conditions

Pain

Study ID

NCT05748119

Start date

Nov 15, 2022

Status verified date

Oct, 2022

Completion date

Oct 1, 2023

Anticipated

Primary completion date

Oct 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

To be eligible for this study, subjects must meet all of the following inclusion criteria:

1. Provides written IRB-approved informed consent prior to any study procedures.
2. Male or female between 18 and 55 years old (inclusive) at the time of screening.
3. In good general health at screening, free from clinically significant unstable medical, surgical or psychiatric illness, at the discretion of the Investigator.
4. Subjects have a BMI between ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
5. Vital signs (measured in supine position after a 5-minute rest) at screening:

1. Systolic blood pressure ≥90 and ≤140 mmHg
2. Diastolic blood pressure ≥50 and ≤ 90 mmHg
3. Heart rate ≥45 and ≤100 bpm
4. Temperature ≥35.5 °C and ≤ 37.5 °C
5. Vital signs may be repeated once, within a minimum of 10 minutes of the completion of the last set of vital signs (while maintaining supine position until the repeated set of vital signs are collected), if it is suspected that falsely high or low levels have been obtained.
6. Adequate venous access to allow collection of multiple blood samples.
7. Negative Covid PCR test upon admission to the CRU.

a. Subjects in Cohort A3 will need a second COVID test prior to admission the CRU for Period 2.
8. No relevant dietary restrictions and willingness to consume standard meals and snacks.
9. Willing to comply with all study procedures and requirements
10. Ability to tolerate the cold pressor test (determined at screening)
11. Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating, and must use two acceptable, highly effective methods of contraception from screening until study completion, including the follow-up period (please see Section 9.4.2 for acceptable methods of contraception). Abstinence as a lifestyle choice is also acceptable. WOCBP must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Day -1 and be willing to have additional pregnancy tests as required throughout the study. WOCBP must also use two acceptable, highly effective methods of contraception from screening until study completion, including the follow-up period and for 30 days after the last dose (please see Section 10.4.2 for acceptable methods of contraception). Women not of childbearing potential must be post menopausal for ≥12 months or be surgically sterile. Hysterectomy with retention of ovary function is permitted. Post-menopausal status will be confirmed through testing of FSH levels ≥ 40 IU/mL at screening for amenorrhoeic female subjects.
12. Male subjects must be surgically sterile (> 30 days since vasectomy per medical history or verbal confirmation), or, if engaged in sexual relations with a WOCBP, the subject and his partner must use two acceptable, highly effective methods of contraception from screening until study completion, including the follow-up period and 30 days after the last dose (please see Section 9.4.2 for acceptable methods of contraception). Abstinence as a lifestyle choice is also acceptable.

Exclusion Criteria:

To be eligible for this study, subjects must not meet any of the following exclusion criteria:

1. Pregnant or lactating at screening or baseline or planning to become pregnant (self or partner) at any time during the study, including the specified follow-up period.
2. History or presence of malignancy at screening or baseline, with the exception of adequately treated localised skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix.
3. Clinically significant infection within 28 days of the start of dosing, or infections requiring parenteral antibiotics within the 6 months prior to screening.
4. Clinically significant surgical procedure within 3 months of screening, at the discretion of the Investigator.
5. Currently suffering from clinically significant systemic allergic disease at screening or baseline or has a history of significant drug allergies including a history of anaphylactic reaction; allergic reaction due to any drug which led to significant morbidity.
6. Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to study treatment administration; corticosteroids are permitted at the discretion of the Investigator), or exposure to any significantly immune suppressing drug within 30 days prior to screening or 5 half lives, whichever is longer.
7. History or presence at screening or baseline of a condition associated with significant immunosuppression.
8. Positive test for hepatitis C (HCV), hepatitis B (HBsAg), COVID, or human immunodeficiency virus (HIV) antibody at screening.
9. Symptoms of dysphagia at screening or baseline or known difficulty in swallowing capsules.
10. Any condition at screening or baseline (eg, chronic diarrhea, inflammatory bowel disease or prior surgery of the gastrointestinal tract) that would interfere with drug absorption or any disease or condition that is likely to affect drug metabolism or excretion, at the discretion of the Investigator.
11. History or presence at screening or baseline of clinically significant cardiac arrhythmia or congenital long QT syndrome.
12. QT interval corrected using Fridericia's formula (QTcF) > 450 msec for males or >470 msec for females.
13. Use of tobacco or nicotine containing products in the previous month prior to dosing or a positive urine cotinine test at Screening or Baseline.
14. Lack of willingness to abstain from the consumption of tobacco or nicotine-containing products throughout the duration of the study and until completion of the final Follow-up visit.
15. Regular alcohol consumption defined as > 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL glass of wine) or the subject is unwilling to abstain from alcohol for 48 h prior to admission and 48 h prior to Follow-up study visit.
16. Positive toxicology screening panel \[urine test, including qualitative identification of barbiturates, tetrahydrocannabinol (THC), amphetamines, benzodiazepines, opiates and cocaine\] or alcohol test (breath or urine) during Screening or at any time during the Study.
17. History of substance abuse or dependency or history of recreational IV drug use, over the last 5 years.
18. Use of any prescription drugs (other than permitted contraception) within 14 days prior to dosing or throughout the duration of the study, without prior approval of the Investigator and written approval of the CRO Medical Monitor.
19. Use of OTC medication including nonsteroidal anti-inflammatory drugs (NSAIDs), herbal remedies, supplements, or vitamins within 7 days prior to dosing. An exception to this is use of acetaminophen up to 4g/day to treat mild discomfort.
20. Use of any investigational drug or device within 30 days or 5 half-lives, whichever is longer, prior to screening.
21. Clinically significant blood loss, or blood or blood product donation >250 mL within 28 days of screening.
22. Subject is unwilling to refrain from strenuous exercise from 7 days prior to admission to the clinical trial unit until completion of the final onsite follow-up visit, where strenuous exercise is defined as a significant increase in the Subject's usual level of physical activity.
23. Any other reason that, in the opinion of the Investigator, might interfere with the evaluation required by the study.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: A1a Placebo

Single Sentinel Placebo Comparator for 20 mg Dose of MEB-1170

experimental: A1a MEB-1170

Single MEB-1170 Sentinel 20 mg Dose

placebo comparator: A1b Placebo

Single Placebo comparator for 20 mg dose cohort of MEB-1170

experimental: A1b MEB-1170

Single MEB-1170 20 mg dose cohort

placebo comparator: A2a Placebo

Single Sentinel Placebo Comparator for 60 mg Dose of MEB-1170

experimental: A2a MEB-1170

Single MEB-1170 Sentinel 60 mg Dose

placebo comparator: A2b Placebo

Single Placebo comparator for 60 mg dose cohort of MEB-1170

experimental: A2b MEB-1170

Single MEB-1170 60 mg dose cohort

placebo comparator: A3a Placebo

Single Sentinel Placebo Comparator for 120 mg Dose of MEB-1170

experimental: A3a MEB-1170

Single MEB-1170 Sentinel 120 mg Dose

placebo comparator: A3b Placebo

Single Placebo comparator for 120 mg dose cohort of MEB-1170

experimental: A3b MEB-1170

Single MEB-1170 120 mg dose cohort

placebo comparator: A4a Placebo

Single Sentinel Placebo Comparator for 200 mg Dose of MEB-1170

experimental: A4a MEB-1170

Single MEB-1170 Sentinel 200 mg Dose

placebo comparator: A4b Placebo

Single Placebo comparator for 200 mg dose cohort of MEB-1170

placebo comparator: A4b MEB-1170

Single MEB-1170 200 mg dose cohort

placebo comparator: A5a Placebo

Single Sentinel Placebo Comparator for 400 mg Dose of MEB-1170

experimental: A5a MEB-1170

Single MEB-1170 Sentinel 400 mg Dose

placebo comparator: A5b Placebo

Single Placebo comparator for 400 mg dose cohort of MEB-1170

experimental: A5b MEB-1170

Single MEB-1170 400 mg dose cohort

placebo comparator: B1 Placebo

MAD Placebo 60 mg comparator cohort of MEB-1170

experimental: B1 MEB-1170

MAD 60 mg MEB-1170 cohort

placebo comparator: B2 Placebo

MAD Placebo 100 mg comparator cohort of MEB-1170

experimental: B2 MEB-1170

MAD 100 mg MEB-1170 cohort

placebo comparator: B3 Placebo

MAD Placebo 200 mg comparator cohort of MEB-1170

experimental: B3 MEB-1170

MAD 200 mg MEB-1170 cohort

placebo comparator: B4 Placebo

MAD Placebo 400 mg comparator cohort of MEB-1170

experimental: B4 MEB-1170

MAD 400 mg MEB-1170 cohort

placebo comparator: A3a Placebo Fed State

Single Sentinel Placebo Comparator for 120 mg Dose of MEB-1170 in Fed State

experimental: A3a MEB-1170 Fed State

Single Sentinel 120 mg Dose of MEB-1170 in Fed State

placebo comparator: A3b Placebo Fed State

Single Placebo comparator for 120 mg dose cohort of MEB-1170 in Fed State

experimental: A3b MEB-1170 Fed State

Single MEB-1170 120 mg dose cohort in Fed State

Interventions

MEB-1170

Depending on the dosage, either 20 mg, 40 mg capsules, or a combination of both

Placebo

Equivalent number and size of capsules containing placebo

Primary outcome measure

  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for hematology [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for hematology [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for hematology [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for hematology [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for hematology [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single Ascending Doses of MEB-1170 for Fasting SAD and MAD laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for blood chemistry [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 including clinical laboratory assessments for urine [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assessed by ECG [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 to assess adverse events [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 to assess suicidality risk [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assess vital signs [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assess vital signs [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assess vital signs [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assess vital signs [ Time Frame: Through study completion, approximately 12 months ]
  • Safety and Tolerability of Single and Multiple Ascending Doses of MEB-1170 assess subjects with a physical exam [ Time Frame: Through study completion, approximately 12 months ]

Central Contacts and Locations

Central contacts

Barbara Lomeli, MD, CPI

816-516-8565barbara.lomeli@labcorp.com

Sunu Valasseri, MBBS, MSc, DPM

+44(0)7882654874s.valasseri@labcorp.com

Locations

Labcorp Clinical Research Unit, Inc

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

Kathleen Doisy, MD

386-366-6400kathleen.doisy@labcorp.com

More Information

Sponsor

Mebias Discovery, Inc

Last update posted

Feb 28, 2023

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mebias Discovery, Inc on 2023-02-28.