A Study of SPY002-091 in Healthy Volunteers

Part of paid clinical trials in Cypress, California.

Sponsor
Spyre Therapeutics, Inc.
Study ID
NCT06672718
Phase
PHASE1
Status
Recruiting

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • SPY002-091 — DRUG
    Experimental
  • Placebo — OTHER
    Placebo

Study Details

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.

Key Dates

Start date
Nov 26, 2024
Status verified
Aug 2025
Primary completion
Feb 18, 2026
Completion
Jun 22, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: SAD Cohorts, Experimental Arm
    Participants will receive a single dose of SPY002-091 in a dose escalation format
  • Placebo Comparator: SAD Cohorts, Placebo Arm
    Participants will receive a single dose of placebo

Primary Outcome Measure

Treatment emergent adverse events [ Time Frame: Up to 40 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spyre Site 1CypressCalifornia90630
Sammy Armado
714-252-0700

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