Recruiting
Phase 1

[Rb-87] with Healthy Volunteers

Sponsor:

Reiley Pharmaceuticals Inc.

Code:

NCT03503825

Conditions

Healthy

Osteo Arthritis Knee

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

[Tc-99m]-RPI-T-087 Injection

Study Details

Brief summary:

The main purpose of this study is to test the safety and tolerability of T-087. The study will enroll 6 healthy volunteers (HVs) and 6-18 subjects with KOA. All eligible subjects will receive an intravenous injection of the radioactive investigational product (ip) (T-087), followed by SPECT/CT imaging of the knees and blood tests and clinical assessments for safety monitoring. Healthy volunteers will also have their whole body imaged and have extra blood drawn to determine where T-087 goes in the body. These additional procedures will be done on the same day as the ip administration, and repeated the following day. All subjects will have a final follow-up phone call within 2- 3 business days following the ip administration.

Conditions

Healthy

Osteo Arthritis Knee

Study ID

NCT03503825

Start date

Aug 16, 2018

Status verified date

Jan, 2019

Completion date

Jun 30, 2019

Anticipated

Primary completion date

May 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria :

  • All subjects must be able to read and speak in English and capable of giving signed informed consent.
  • Female subjects must either, not be of reproductive potential, or not be pregnant and be willing to comply with appropriate family planning methods as specified in the protocol.
  • Male subjects must either, not be of reproductive potential or be willing to comply with appropriate family planning methods as specified in the protocol.

Subjects with Knee Osteoarthritis (KOA)

  • Age ≥ 40 to ≤ 70 years, at the time of signing the informed consent
  • Have chronic pain due to OA of at least one knee identifiable as the target knee as their primary pain condition and some degree of pain every day from this condition.

For Healthy Volunteers:

  • Age ≥ 18 to ≤ 35 years, at the time of signing the informed consent.
  • No history of knee pain or known knee pathology confirmed by knee radiographs, obtained within the last year.

Exclusion Criteria:

  • Chronic pain conditions other than OA of the knee (KOA) as their predominant pain condition
  • Cannot or will not agree to stop: all topical, oral and parenteral non-steroidal anti-inflammatory drugs (NSAIDs) for at least 48 hours before administration of the IP; stop turmeric and curcumin (supplements and dietary sources) for at least 48 hours before administration of the IP; avoid all exercise from at least 24 hours before administration of the IP up to the end of the last applicable imaging session.
  • Systemic (including inhaled) and oral corticosteroid use currently or within 6 weeks prior to Visit 1.
  • Surgical interventions of either knee or any other major surgery within the previous 6 months.
  • Receipt of intra-articular corticosteroid injections within the previous 6 weeks prior to Visit 1 in the target knee or within the previous 2 weeks prior to Visit 1 in any other joint.
  • Use of any other investigational medication or devices within 30 days prior to Visit 1.
  • Orthopedic or prosthetic appliance in either knee which may confound scan interpretation.
  • Screening ECG or laboratory assessments showing clinically significant abnormalities
  • Refusal or inability to tolerate the scanning procedures
  • Allergies to or cannot tolerate NSAIDs, the investigational product or sulfa drugs
  • History of bleeding disorders or history of documented gastrointestinal ulcer disease.
  • Received significant ionizing radiation exposure, in the last 12 months or undergoing occupational monitoring for radiation exposure.
  • Allergies or sensitivity to any component of the investigational product. Subjects taking disulfiram (Antabuse) should be excluded from this study.
  • History of alcohol or substance abuse
  • Any medical condition or disease that in the opinion of the investigator makes the subject unsuitable to participate in this study.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Healthy Volunteers

Healthy volunteers will be administered \[Tc-99m\]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety, knee image evaluation, and radioactivity biodistribution and dosimetry.

experimental: Osteo Arthritis of the knee

Subjects with knee osteoarthritis will be administered \[Tc-99m\]-RPI-T-087 Injection, single IV dose of 555 MBq and will be monitored for safety and knee image evaluation.

Interventions

[Tc-99m]-RPI-T-087 Injection

A single intravenous injection of \[Tc-99m\]-RPI-T-087 followed by SPECT/CT imaging of the knee (all subjects) and whole body planar imaging (Healthy volunteers only)

Primary outcome measure

  • Incidence of treatment emergent adverse events [ Time Frame: Up to 3 days post investigative product administration ]

Central Contacts and Locations

Central contacts

Janet Crouch, BScc, MRT(N)

(905) 522-1155jcrouch@stjoes.ca

MaryLou Lawlor, RN

(905) 522-1155mlawlor@stjosham.on.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada

Contacts

Janet Crouch, RTNM

(905) 522-1155

MaryLou, RN

(905) 522-1155

Principal Investigator:

Karen Gulenchyn, MD

More Information

Sponsor

Reiley Pharmaceuticals Inc.

Last update posted

Jan 15, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Reiley Pharmaceuticals Inc. on 2019-01-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.