A Study of SPY002-072 in Healthy Volunteers

NCT06622070 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SPY002-072-101
• Study Type: interventional
• Target: 56
• 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 SPY002-072 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

• t1/2

  Up to 40 weeks

• Tmax

  Up to 40 weeks

• ADA

  Up to 40 weeks

• AUC

  Up to 40 weeks

Study Arms (2)

SAD Cohorts, Experimental Arm

EXPERIMENTAL

Participants will receive a single dose of SPY002-072 in a dose escalation format

Drug: SPY002-072

SAD Cohorts, Placebo Arm

PLACEBO COMPARATOR

Participants will receive a single dose of placebo

Other: Placebo

Interventions

SPY002-072 DRUG

Experimental

SAD Cohorts, Experimental Arm

Placebo OTHER

Placebo

SAD Cohorts, Placebo 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, 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

Sponsors & Collaborators

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

Study Sites (2)

Spyre Site 2

Cypress, California, 90630, United States

NOT YET RECRUITING

Spyre Site 1

Montreal, Quebec, H3P 3P1, Canada

RECRUITING

Study Officials

• Joshua Friedman, MD

  Spyre Therapeutics

  STUDY CHAIR

Central Study Contacts

Medical Director, Clinical Development

CONTACT

617-651-5940; Spyre_SPY002-072-101@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: September 30, 2024
• First Posted: October 1, 2024
• Study Start: November 18, 2024
• Primary Completion: April 3, 2026
• Study Completion (Estimated): August 8, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)