Recruiting
Phase 1

DTI-117

Sponsor:

Dignify Therapeutics

Code:

NCT07882472

Conditions

Healthy Adult

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

DTI-117

Placebo

Study Details

Brief summary:

This is a single ascending dose, double-blind, placebo-controlled, randomized evaluation of the safety, tolerability, and pharmacokinetics of DTI-117 in healthy volunteers. There will be up to five cohorts of 8 healthy participants each cohort.

Conditions

Healthy Adult

Study ID

NCT07882472

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Provide written informed consent to participate.
  • Adult male and female healthy volunteers between 18 to 65 years of age, inclusive.
  • General good health, with no clinically relevant abnormalities as determined by the medical history, physical exam, ECG, and clinical laboratory results.
  • Screening body weight between 45 and 100 kg, inclusive, with body mass index (BMI) ≤32 kg/m2.

Exclusion Criteria:

  • Gastrointestinal or urological surgery in the previous 6 months.
  • Presence of any clinically significant infectious, cardiac, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, in the opinion of the investigator.
  • History of colitis.
  • Current chronic intermittent constipation requiring medication more than twice per month.
  • Use of any investigational drug within 30 days of Screening or 5 drug half-lives, whichever is longer.
  • Individuals not willing or unable to tolerate blood draws or individuals with poor venous access.
  • Presence or history of any condition that, in the opinion of the Investigator, might reasonably jeopardize the safety of the participant, the ability to collect study data, or the validity of the study results.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 0.03 mg/kg DTI-117

Participants receive a single IM dose of DTI-117 0.03 mg/kg.

experimental: 0.05 mg/kg DTI-117

Participants receive a single IM dose of DTI-117 0.05 mg/kg.

experimental: 0.1 mg/kg DTI-117

Participants receive a single IM dose of DTI-117 0.1 mg/kg.

experimental: 0.2 mg/kg DTI-117

Participants receive a single IM dose of DTI-117 0.2 mg/kg.

experimental: 0.3 mg/kg DTI-117

Participants receive a single IM dose of DTI-117 0.3 mg/kg.

placebo comparator: Placebo

Participants randomized to placebo within each cohort receive a single intramuscular injection of 0.9% Sodium Chloride Injection, USP.

Interventions

DTI-117

Single intramuscular injection of DTI-117 at the assigned dose level.

Placebo

Single intramuscular injection of 0.9% Sodium Chloride Injection, USP.

Primary outcome measure

  • Number of participants with adverse events [ Time Frame: Up to seven days ]
  • Number of participants with abnormal lab test results [ Time Frame: Up to seven days ]
  • Number of participants with abnormal vital signs [ Time Frame: Up to seven days ]
  • Number of participants with abnormal ECG [ Time Frame: Up to seven days ]

Central Contacts and Locations

Central contacts

Ed Burgard, PhD

919-371-8138eburgard@dignifytherapeutics.com

Karl Thor, PhD

919-371-8138kthor@dignifytherapeutics.com

Locations

Thermo Fisher

Recruiting

Austin, Texas, United States, 78744

Contacts

Katherine Sides, MD

737-320-5556katherine.sides@trialmed.com

More Information

Sponsor

Dignify Therapeutics

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Dignify Therapeutics on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.