A Study of SPY001-001 in Healthy Volunteers

Spyre Therapeutics, Inc.

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: SPY001-001; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06448247

SPY001-101

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 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, 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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96 participants in 8 patient groups, including a placebo group

SAD Cohorts 1-5 Experimental Arm

Experimental group

Description:

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

Treatment:

Drug: SPY001-001

SAD Cohorts 1-5 Placebo Arm

Placebo Comparator group

Description:

Participants will receive a single dose of placebo

Treatment:

Other: Placebo

MAD Cohorts 1-3 Experimental Arm

Experimental group

Description:

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

Treatment:

Drug: SPY001-001

MAD Cohorts 1-3 Placebo Arm

Placebo Comparator group

Description:

Participants will receive two doses of placebo

Treatment:

Other: Placebo

SAD Cohorts 6-7 Experimental Arm

Experimental group

Description:

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

Treatment:

Drug: SPY001-001

SAD Cohorts 6-7 Placebo Arm

Placebo Comparator group

Description:

Participants of Japanese descent will receive a single dose of placebo

Treatment:

Other: Placebo

SAD Cohorts 8-9 Experimental Arm

Experimental group

Description:

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

Treatment:

Drug: SPY001-001

SAD Cohorts 8-9 Placebo Arm

Placebo Comparator group

Description:

Participants of Chinese descent will receive a single dose of placebo

Treatment:

Other: Placebo