A Study of SPY003-207 in Healthy Volunteers

March 18, 2026 updated by: Spyre Therapeutics, Inc.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY003-207 in Healthy Participants

This is a Phase 1, randomized, double-blind, placebo-controlled, single dose, first in human safety, tolerability, and pharmacokinetic study of SPY003-207 in healthy participants.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: SAD Cohorts 1-6 Placebo Arm
Participants will receive a single dose of placebo
Other: Placebo
Placebo
Experimental: SAD Cohorts 1-6 Experimental Arm
Participants will receive a single dose of SPY003-207 in a dose escalation format
Drug: SPY003-207
Experimental
Experimental: SAD Cohort 7, Experimental Arm
Participants of Chinese descent will receive a single dose of SPY003-207-101
Drug: SPY003-207
Experimental
Placebo Comparator: SAD Cohort 7, Placebo Arm
Participants of Chinese descent will receive a single dose of placebo
Other: Placebo
Placebo
Experimental: MAD Cohorts 1 Experimental Arm
Participants will receive two doses of SPY003-207-101 in a dose escalation format
Drug: SPY003-207
Experimental
Placebo Comparator: MAD Cohorts 1 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
Time Frame: Up to 63 weeks
Incidence, severity, and causal relationship of TEAEs
Up to 63 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Up to 63 weeks
Maximum concentration after a single dose
Up to 63 weeks
Tmax
Time Frame: Up to 63 weeks
Time to reach maximum concentration after a single dose
Up to 63 weeks
t1/2
Time Frame: Up to 63 weeks
Half life after a single dose
Up to 63 weeks
AUC
Time Frame: Up to 63 weeks
Area under the curve after a single dose
Up to 63 weeks
ADA
Time Frame: Up to 63 weeks
Incidence of anti-drug antibody after a single dose
Up to 63 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spyre Therapeutics, Inc.

Collaborators

Altasciences Company Inc.

Investigators

  • Study Chair: Deanna Nguyen, MD, Spyre Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

November 18, 2026

Study Completion (Estimated)

November 18, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SPY003-207-101

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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