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Healthy Volunteers for Healthy Subjects

Phase 1
Waitlist Available
Led By Karen Gulenchyn, MD
Research Sponsored by Reiley Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 hours post administration of the investigational product
Awards & highlights

Study 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.

Eligible Conditions
  • Healthy Subjects
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 hours post administration of the investigational product
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 hours post administration of the investigational product for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment emergent adverse events
Secondary outcome measures
Dosimetry
Image quality
Uptake over time
Other outcome measures
Clearance of [Tc-99m]-RPI-T-087

Trial Design

2Treatment groups
Experimental Treatment
Group I: Osteo Arthritis of the kneeExperimental Treatment1 Intervention
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.
Group II: Healthy VolunteersExperimental Treatment1 Intervention
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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Reiley Pharmaceuticals Inc.Lead Sponsor
Karen Gulenchyn, MDPrincipal InvestigatorSt. Joseph's Hospital Hamilton
2 Previous Clinical Trials
177 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
[Tc-99m]-RPI-087 as an Imaging Marker in Osteoarthritis of the Knee Compared to Healthy Volunteers
2018. "[Tc-99m]-RPI-087 as an Imaging Marker in Osteoarthritis of the Knee Compared to Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03503825.
All > Oa
~4 spots leftby Apr 2025
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