Testing SPY003-207 for safety in healthy volunteers
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY003-207 in Healthy Participants
This study is testing a new drug called SPY003-207 to see if it's safe for healthy people to take.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Spyre Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT06873724 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial is designed to evaluate the safety, tolerability, and pharmacokinetics of SPY003-207 in healthy participants. It employs a randomized, double-blind, placebo-controlled methodology, where participants will receive either the investigational drug or a placebo in a single dose. The study aims to gather essential data on how the drug behaves in the human body and its potential side effects. Participants will be monitored closely during their stay at the clinical research unit and will return for follow-up visits.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy men and women who can comply with study requirements and attend all necessary visits.
Not a fit: Patients with significant health abnormalities, a history of substance abuse, or severe allergic reactions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical safety data that may support the future development of SPY003-207 for therapeutic use.
How similar studies have performed: Other Phase 1 studies have successfully established safety profiles for new drugs, making this approach a standard practice in drug development.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy men and women * Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits Exclusion Criteria: * Participation in more than one cohort * Evidence of clinically significant abnormality or disease * Known history of illicit drug use or drug abuse, harmful alcohol use or alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study drug * History of severe allergic reactions or hypersensitivity * Donation or loss of \>1 unit of whole blood within 1 month prior to dosing
Where this trial is running
Montréal, Quebec
- Spyre Site 1 — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Medical Director, Clinical Development
- Email: Spyre_SPY003-207@spyre.com
- Phone: 910-616-0894
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.