SPY003-207 for Healthy Subjects

Recruiting at 1 trial location

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 trial tests the safety and behavior of a new treatment called SPY003-207 (experimental treatment) in the body. It is the first study in humans, with some participants receiving the actual treatment and others a placebo (a harmless pill with no effect). The goal is to understand treatment tolerance and bodily processing. The trial seeks healthy men and women willing to visit the study site for check-ups and stay for the required period. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that taking medications might affect eligibility. It's best to discuss your specific situation with the trial coordinators.

Is there any evidence suggesting that SPY003-207 is likely to be safe for humans?

Research has shown that SPY003-207 is well-tolerated at all tested doses. Its safety profile is similar to other drugs in the anti-IL-23 group, which reduce inflammation. As this treatment is in its first human trials, researchers continue to closely monitor its safety. However, these early results are promising for potential study participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SPY003-207 because it offers a fresh approach to treatment with its novel mechanism of action. Unlike many existing treatments that rely on traditional pathways, SPY003-207 targets specific biological processes in a new way, potentially leading to better outcomes. This unique targeting could result in increased effectiveness and fewer side effects, making it a promising candidate for future therapies.

What evidence suggests that SPY003-207 could be effective?

Research has shown that SPY003-207 appears promising in early studies. Participants tolerated it well, and it remains in the body for about 85 days. This suggests it might be effective with just a few doses each year. In this trial, participants will receive either a single dose of SPY003-207 or a placebo. While specific data on its effectiveness for a particular condition is not yet available, its long-lasting effect indicates it could be taken less frequently. This might make it a convenient option if future studies demonstrate its benefits for certain health issues. ^{1 2 3 4 6}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06873724

NCT06873724 | SPY003-207 in Healthy Volunteers It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. ir.spyre.com ir.spyre.com/news-releases/news-release-details/spyre-therapeutics-announces-positive-interim-phase-1-results-0

Release Details SPY003 was well tolerated and exhibited an ~85-day half-life, supporting potential quarterly or twice annual maintenance dosing.

3. withpower.com withpower.com/trial/spy003-207-for-healthy-subjects-3d8aa

SPY003-207 for Healthy Subjects This is a Phase 1, randomized, double-blind, placebo-controlled, single dose, first in human safety, tolerability, and pharmacokinetic study of SPY003-207 in ...

4. trial.medpath.com trial.medpath.com/clinical-trial/40e522cdeec7d853/nct06873724-spy003-207-safety-tolerability-pharmacokinetics

SPY003-207 in Healthy Volunteers | MedPath This is a Phase 1, randomized, double-blind, placebo-controlled, single dose, first in human safety, tolerability, and pharmacokinetic study of SPY003-207 in ...

5. trialx.com trialx.com/clinical-trials/listings/315051/spy003-207-in-healthy-volunteers/

SPY003-207 in Healthy Volunteers This is a Phase 1, randomized, double-blind, placebo-controlled, single dose, first in human safety, tolerability, and pharmacokinetic study of SPY003-207 in ...

6. tipranks.com tipranks.com/news/company-announcements/spyre-therapeutics-advances-with-phase-1-study-of-spy003-207

Spyre Therapeutics Advances with Phase 1 Study of ... ' The study aims to evaluate the safety, tolerability, and pharmacokinetics of SPY003-207, marking its first human trial. This research is ...