SPY003-207 for Healthy Subjects

Overseen By Medical Director, Clinical Development

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Spyre Therapeutics, Inc.

Disqualifiers: Drug abuse, Alcoholism, Smoking, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Deanna Nguyen, MD

Principal Investigator

Spyre Therapeutics

Are You a Good Fit for This Trial?

This trial is for healthy men and women who can commit to staying at the study site for a set time and return for follow-up visits. People with significant health issues, recent blood donations, severe allergies, drug or alcohol abuse history, or nicotine use in the past 3 months cannot participate.

Inclusion Criteria

I am a healthy man or woman.

I can attend all required study visits and stay for the needed duration.

Exclusion Criteria

Participation in more than one cohort

Evidence of clinically significant abnormality or disease

I have not donated or lost more than 1 unit of blood in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

63 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPY003-207

Trial Overview The trial is testing SPY003-207 against a placebo in healthy volunteers. It's the first test of this drug in humans to check its safety, how well it's tolerated, and what happens to it inside the body after taking just one dose.

How Is the Trial Designed?

Group I: SAD Cohorts 1-6 Experimental Arm Experimental Treatment 1 Intervention

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

Group II: SAD Cohorts 1-6 Placebo Arm Placebo Group 1 Intervention

Participants will receive a single dose of placebo

Who Is Running the Clinical Trial?

Spyre Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

270+

Altasciences Company Inc.

Industry Sponsor

Trials

18

Recruited

860+