A Study of SPY003-207 in Healthy Volunteers

NCT06873724 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: SPY003-207-101
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events

  Incidence, severity, and causal relationship of TEAEs

  Up to 63 weeks

Secondary Outcomes (5)

• Cmax

  Up to 63 weeks

• Tmax

  Up to 63 weeks

• t1/2

  Up to 63 weeks

• AUC

  Up to 63 weeks

• ADA

  Up to 63 weeks

Study Arms (6)

SAD Cohorts 1-6 Experimental Arm

EXPERIMENTAL

Participants will receive a single dose of SPY003-207 in a dose escalation format

Drug: SPY003-207

SAD Cohorts 1-6 Placebo Arm

PLACEBO COMPARATOR

Participants will receive a single dose of placebo

Other: Placebo

SAD Cohort 7, Experimental Arm

EXPERIMENTAL

Participants of Chinese descent will receive a single dose of SPY003-207-101

Drug: SPY003-207

SAD Cohort 7, Placebo Arm

PLACEBO COMPARATOR

Participants of Chinese descent will receive a single dose of placebo

Other: Placebo

MAD Cohorts 1 Experimental Arm

EXPERIMENTAL

Participants will receive two doses of SPY003-207-101 in a dose escalation format

Drug: SPY003-207

MAD Cohorts 1 Placebo Arm

PLACEBO COMPARATOR

Participants will receive two doses of placebo

Other: Placebo

Interventions

Placebo OTHER

Placebo

MAD Cohorts 1 Placebo Arm; SAD Cohort 7, Placebo Arm; SAD Cohorts 1-6 Placebo Arm

SPY003-207 DRUG

Experimental

MAD Cohorts 1 Experimental Arm; SAD Cohort 7, Experimental Arm; SAD Cohorts 1-6 Experimental Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 (2)

Spyre Site 2

Cypress, California, 90630, United States

Location

Spyre Site 1

Montreal, Quebec, H3P 3P1, Canada

Location

Study Officials

• Deanna Nguyen, MD

  Spyre Therapeutics

  STUDY CHAIR

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: March 7, 2025
• First Posted: March 13, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 18, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)