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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06448247
Other study ID # SPY001-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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