A Study of SPY002-091 in Healthy Volunteers

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: SPY002-091; Other: Placebo

• Registration Number: NCT06672718
• Lead Sponsor: Spyre Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Last Update Submitted: 2024-11-04
• Study Start: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-02-18
• Study Completion: 2026-06-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SAD Cohorts, Experimental Arm	SPY002-091	Participants will receive a single dose of SPY002-091 in a dose escalation format
SAD Cohorts, Placebo Arm	Placebo	Participants will receive a single dose of placebo

Primary Outcome Measures

Name	Time	Method
Treatment emergent adverse events	Up to 40 weeks	Incidence, severity, and causal relationship of TEAEs

Secondary Outcome Measures

Name	Time	Method
Cmax	Up to 40 weeks	Maximum concentration after single ascending doses
Tmax	Up to 40 weeks	Time to reach maximum concentration after single ascending doses
AUC	Up to 40 weeks	Area under the curve after single ascending doses
t1/2	Up to 40 weeks	Half life after single ascending doses
ADA	Up to 40 weeks	Incidence of anti-drug antibody after single ascending doses

Trial Locations

Locations (1)

Spyre Site 1; 🇺🇸 Cypress, California, United States