A Study of SPY001-001 in Healthy Volunteers

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Other: Placebo; Drug: SPY001-001

• Registration Number: NCT06448247
• Lead Sponsor: Spyre Therapeutics, Inc.

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose, first in human safety, tolerability, and pharmacokinetic study of SPY001-001 in healthy participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-03
• Study Start: 2024-06-06
• Study First Posted: 2024-06-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-08-02
• Study Completion: 2025-08-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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
MAD Cohorts 1-3 Placebo Arm	Placebo	Participants will receive two doses of placebo
SAD Cohorts 6-7 Experimental Arm	SPY001-001	Participants of Japanese descent will receive a single dose of SPY001-001
SAD Cohorts 6-7 Placebo Arm	Placebo	Participants of Japanese descent will receive a single dose of placebo
SAD Cohorts 8-9 Experimental Arm	SPY001-001	Participants of Chinese descent will receive a single dose of SPY001-001
SAD Cohorts 8-9 Placebo Arm	Placebo	Participants of Chinese descent will receive a single dose of placebo
MAD Cohorts 1-3 Experimental Arm	SPY001-001	Participants will receive two doses of SPY001-001 in a dose escalation format
SAD Cohorts 1-5 Experimental Arm	SPY001-001	Participants will receive a single dose of SPY001-001 in a dose escalation format
SAD Cohorts 1-5 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 and multiple ascending doses
ADA	Up to 40 weeks	Incidence of anti-drug antibody after single and multiple ascending doses
Tmax	Up to 40 weeks	Time to reach maximum concentration after single and multiple ascending doses
t1/2	Up to 40 weeks	Half life after single and multiple doses
AUC	Up to 40 weeks	Area under the curve after single and multiple ascending doses

Trial Locations

Locations (2)

Spyre Site 1; 🇨🇦 Montréal, Quebec, Canada

Spyre Site 2; 🇺🇸 Cypress, California, United States