RecruitingPhase 1NCT06672718

A Study of 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

Sponsor

Spyre Therapeutics, Inc.

Enrollment

56 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single- dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-091 in healthy participants.

Eligibility

Min Age: 18 YearsMax Age: 65 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, 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

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