Testing SPY002-091 in healthy volunteers
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY002-091 in Healthy Participants
This study is testing a new drug called SPY002-091 in healthy volunteers to see if it is safe and how it works in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Spyre Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Cypress, California) |
| Trial ID | NCT06672718 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial is designed to evaluate the safety, tolerability, and pharmacokinetics of a single dose of SPY002-091 in healthy participants. The study employs a randomized, double-blind, placebo-controlled methodology to ensure unbiased results. Participants will be monitored closely during their stay at the clinical research unit and will return for outpatient visits to assess the drug's effects. The trial aims to gather essential data on how the drug behaves in the human body.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy men and women who can comply with the study's visit requirements.
Not a fit: Patients with significant health issues or a history of substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical safety and efficacy data for SPY002-091, paving the way for future studies in patients.
How similar studies have performed: Other Phase 1 studies have successfully evaluated similar drug candidates, indicating a promising approach.
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
Cypress, California
- Spyre Site 1 — Cypress, California, United States (Recruiting)
Study contacts
- Study coordinator: Medical Director, Clinical Development
- Email: Spyre_SPY002-091-101@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.