A Study of SPY002-091 in Healthy Volunteers

NCT06672718 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SPY002-091-101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single- dose, first in human safety, tolerability, and pharmacokinetic study of SPY002-091 in healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events

  Incidence, severity, and causal relationship of TEAEs

  Up to 40 weeks

Secondary Outcomes (5)

• Cmax

  Up to 40 weeks

• Tmax

  Up to 40 weeks

• AUC

  Up to 40 weeks

• t1/2

  Up to 40 weeks

• ADA

  Up to 40 weeks

Study Arms (2)

SAD Cohorts, Experimental Arm

EXPERIMENTAL

Participants will receive a single dose of SPY002-091 in a dose escalation format

Drug: SPY002-091

SAD Cohorts, Placebo Arm

PLACEBO COMPARATOR

Participants will receive a single dose of placebo

Other: Placebo

Interventions

SPY002-091 DRUG

Experimental

Also known as: SPY002

SAD Cohorts, Experimental Arm

Placebo OTHER

Placebo

SAD Cohorts, Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spyre Therapeutics, Inc.: lead
• Altasciences Company Inc.: collaborator

Study Sites (1)

Spyre Site 1

Cypress, California, 90630, United States

RECRUITING

Study Officials

• Joshua Friedman, MD

  Spyre Therapeutics

  STUDY CHAIR

Central Study Contacts

Medical Director, Clinical Development

CONTACT

617-651-5940; Spyre_SPY002-091-101@spyre.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: November 26, 2024
• Primary Completion: February 18, 2026
• Study Completion (Estimated): June 22, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)