Testing SPY002-072 in healthy volunteers
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY002-072 in Healthy Participants
This study is testing a new drug called SPY002-072 in healthy volunteers to see how safe it is and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Spyre Therapeutics, Inc. Industry-sponsored |
| Locations | 2 sites (Cypress, California and 1 other locations) |
| Trial ID | NCT06622070 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial is designed to evaluate the safety, tolerability, and pharmacokinetics of SPY002-072 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 format. The study aims to gather essential data on how the drug behaves in the human body and its potential side effects. Healthy volunteers 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 recent blood donation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and pharmacokinetics of SPY002-072, paving the way for future therapeutic applications.
How similar studies have performed: While this study is focused on a specific investigational drug, similar Phase 1 trials have successfully established safety profiles for new medications.
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, cannabis/cannabinoid use, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent * 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
Cypress, California and 1 other locations
- Spyre Site 2 — Cypress, California, United States (Not_yet_recruiting)
- Spyre Site 1 — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Medical Director, Clinical Development
- Email: Spyre_SPY002-072-101@spyre.com
- Phone: 617-651-5940
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.