A Study of SPY001-001 in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Drug: SPY001-001

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3P 3P1
      • Spyre Site 1
• United States
  • California
    • Cypress, California, United States, 90630
      • Spyre Site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD Cohorts 1-5 Experimental Arm; Participants will receive a single dose of SPY001-001 in a dose escalation format	Drug: SPY001-001; Experimental
Placebo Comparator: SAD Cohorts 1-5 Placebo Arm; Participants will receive a single dose of placebo	Other: Placebo; Placebo
Experimental: SAD Cohorts 6-7 Experimental Arm; Participants of Japanese descent will receive a single dose of SPY001-001	Drug: SPY001-001; Experimental
Placebo Comparator: SAD Cohorts 6-7 Placebo Arm; Participants of Japanese descent will receive a single dose of placebo	Other: Placebo; Placebo
Experimental: SAD Cohorts 8-9 Experimental Arm; Participants of Chinese descent will receive a single dose of SPY001-001	Drug: SPY001-001; Experimental
Placebo Comparator: SAD Cohorts 8-9 Placebo Arm; Participants of Chinese descent will receive a single dose of placebo	Other: Placebo; Placebo
Experimental: MAD Cohorts 1-2 Experimental Arm; Participants will receive two doses of SPY001-001 in a dose escalation format	Drug: SPY001-001; Experimental
Placebo Comparator: MAD Cohorts 1-2 Placebo Arm; Participants will receive two doses of placebo	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment emergent adverse events	Incidence, severity, and causal relationship of TEAEs	Up to 64 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum concentration after single and multiple ascending doses	Up to 64 weeks
Tmax	Time to reach maximum concentration after single and multiple ascending doses	Up to 64 weeks
t1/2	Half life after single and multiple doses	Up to 64 weeks
AUC	Area under the curve after single and multiple ascending doses	Up to 64 weeks
ADA	Incidence of anti-drug antibody after single and multiple ascending doses	Up to 64 weeks

Collaborators and Investigators

• Sponsor: Spyre Therapeutics, Inc.
• Collaborators: Altasciences Company Inc.
• Investigators: Study Chair: Deanna Nguyen, MD, Spyre Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Actual): March 10, 2026
• Study Completion (Actual): March 10, 2026

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SPY001-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No