A Study of SPY002-072 in Healthy Volunteers

November 25, 2024 updated by: Spyre Therapeutics, Inc.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY002-072 in Healthy Participants

This is a Phase 1, randomized, double-blind, placebo-controlled, single-dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-072 in healthy participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

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 Contact

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3P 3P1
        • Recruiting
        • Spyre Site 1
        • Contact:
  • United States
    • California
      • Cypress, California, United States, 90630

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, cannabis/cannabinoid use, harmful alcohol use (at the Investigator's discretion), alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study agent
  • 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
Experimental: SAD Cohorts, Experimental Arm
Participants will receive a single dose of SPY002-072 in a dose escalation format
Drug: SPY002-072
Experimental
Placebo Comparator: SAD Cohorts, Placebo Arm
Participants will receive a single dose 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 40 weeks
Incidence, severity, and causal relationship of TEAEs
Up to 40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Up to 40 weeks
Maximum concentration after single dose
Up to 40 weeks
t1/2
Time Frame: Up to 40 weeks
Half life after single dose
Up to 40 weeks
Tmax
Time Frame: Up to 40 weeks
Time to reach maximum concentration after single dose
Up to 40 weeks
ADA
Time Frame: Up to 40 weeks
Incidence of anti-drug antibody after single dose
Up to 40 weeks
AUC
Time Frame: Up to 40 weeks
Area under the curve after single dose
Up to 40 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: Joshua Friedman, 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)

November 18, 2024

Primary Completion (Estimated)

April 3, 2026

Study Completion (Estimated)

August 8, 2026

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SPY002-072-101

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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