A Study of SPY001-001 in Healthy Volunteers

NCT06448247 | Completed Phase 1 FDA Drug

• 1 other identifier: SPY001-101
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose, first in human safety, tolerability, and pharmacokinetic study of SPY001-001 in healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Treatment emergent adverse events

  Incidence, severity, and causal relationship of TEAEs

  Up to 64 weeks

Secondary Outcomes (5)

• Cmax

  Up to 64 weeks

• Tmax

  Up to 64 weeks

• t1/2

  Up to 64 weeks

• AUC

  Up to 64 weeks

• ADA

  Up to 64 weeks

Study Arms (8)

SAD Cohorts 1-5 Experimental Arm

EXPERIMENTAL

Participants will receive a single dose of SPY001-001 in a dose escalation format

Drug: SPY001-001

SAD Cohorts 1-5 Placebo Arm

PLACEBO COMPARATOR

Participants will receive a single dose of placebo

Other: Placebo

MAD Cohorts 1-2 Experimental Arm

EXPERIMENTAL

Participants will receive two doses of SPY001-001 in a dose escalation format

Drug: SPY001-001

MAD Cohorts 1-2 Placebo Arm

PLACEBO COMPARATOR

Participants will receive two doses of placebo

Other: Placebo

SAD Cohorts 6-7 Experimental Arm

EXPERIMENTAL

Participants of Japanese descent will receive a single dose of SPY001-001

Drug: SPY001-001

SAD Cohorts 6-7 Placebo Arm

PLACEBO COMPARATOR

Participants of Japanese descent will receive a single dose of placebo

Other: Placebo

SAD Cohorts 8-9 Experimental Arm

EXPERIMENTAL

Participants of Chinese descent will receive a single dose of SPY001-001

Drug: SPY001-001

SAD Cohorts 8-9 Placebo Arm

PLACEBO COMPARATOR

Participants of Chinese descent will receive a single dose of placebo

Other: Placebo

Interventions

Placebo OTHER

Placebo

MAD Cohorts 1-2 Placebo Arm; SAD Cohorts 1-5 Placebo Arm; SAD Cohorts 6-7 Placebo Arm; SAD Cohorts 8-9 Placebo Arm

SPY001-001 DRUG

Experimental

MAD Cohorts 1-2 Experimental Arm; SAD Cohorts 1-5 Experimental Arm; SAD Cohorts 6-7 Experimental Arm; SAD Cohorts 8-9 Experimental 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

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

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: June 3, 2024
• First Posted: June 7, 2024
• Study Start: June 6, 2024
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)