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New drug SPY001-001 tested in healthy people for first time

NCT ID NCT06448247

Knowledge-focused Sponsor: Spyre Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested the safety and tolerability of a new drug called SPY001-001 in 96 healthy volunteers. Participants received either the drug or a placebo, and researchers monitored side effects and how the drug moves through the body. Since this is a first-in-human study, the main goal is to gather basic safety information, not to treat any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SPY001-001

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

96 people

The number who actually took part.

Started

Jun 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • Spyre Site 1

    Montreal, Quebec, H3P 3P1, Canada

  • Spyre Site 2

    Cypress, California, 90630, United States

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