A Study of SPY001-001 in Healthy Volunteers

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY001-001 in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448247
• Other study ID #: SPY001-101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 6, 2024
• Est. completion date: August 2, 2025

Study information

• Verified date: June 2024
• Source: Spyre Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2, 2025
• Est. primary completion date: August 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy men and women of non-childbearing potential
• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SPY001-001
Experimental

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Spyre Site 1	Montréal	Quebec
United States	Spyre Site 2	Cypress	California

Sponsors (2)

Lead Sponsor	Collaborator
Spyre Therapeutics, Inc.	Altasciences Company Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent adverse events	Incidence, severity, and causal relationship of TEAEs	Up to 40 weeks
Secondary	Cmax	Maximum concentration after single and multiple ascending doses	Up to 40 weeks
Secondary	Tmax	Time to reach maximum concentration after single and multiple ascending doses	Up to 40 weeks
Secondary	t1/2	Half life after single and multiple doses	Up to 40 weeks
Secondary	AUC	Area under the curve after single and multiple ascending doses	Up to 40 weeks
Secondary	ADA	Incidence of anti-drug antibody after single and multiple ascending doses	Up to 40 weeks