RecruitingPhase 1NCT06622070

A Study of 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


Sponsor

Spyre Therapeutics, Inc.

Enrollment

56 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-072 in healthy participants.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

  • 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 Criteria5

  • 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

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Interventions

DRUGSPY002-072

Experimental

OTHERPlacebo

Placebo


Locations(2)

Spyre Site 2

Cypress, California, United States

Spyre Site 1

Montreal, Quebec, Canada

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NCT06622070


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