A Study of SPY002-072 in Healthy Volunteers

Spyre Therapeutics, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: SPY002-072; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06622070

SPY002-072-101

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

SAD Cohorts, Experimental Arm

Experimental group

Description:

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

Treatment:

Drug: SPY002-072

SAD Cohorts, Placebo Arm

Placebo Comparator group

Description:

Participants will receive a single dose of placebo

Treatment:

Other: Placebo