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New drug SL-325 tested in healthy volunteers for safety

NCT ID NCT07158437

Knowledge-focused Sponsor: Shattuck Labs, 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-stage study is testing a new drug, SL-325, in 72 healthy volunteers to see if it is safe and how the body processes it. Participants receive either the drug or a placebo, and researchers monitor for side effects. This study does not aim to treat any disease but to gather important safety information before testing in patients.

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

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

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 55 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: 1. Provide signed informed consent 2. 18-55 years of age, inclusive, at the time of signing the informed consent form 3. Body mass index of 18-32 kg/m2, inclusive, and a total body weight \> 50 kg 4. Laboratory values within normal limits or any abnormalities deemed not clinically significant by the Investigator 5. Participant agrees to practice birth control measures Exclusion Criteria: 1. History or presence of a clinically significant infectious disease or hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, neurologic, or psychiatric abnormality 2. Any clinically significant abnormality on vital signs, electrocardiogram (ECG), or laboratory parameters 3. History of regular alcohol consumption within 6 months of Screening 4. Positive test for use of drugs or alcohol at Screening 5. History of use of tobacco- or nicotine-containing products within 3 months of Screening 6. History of infusion-related reaction or allergic reaction upon receipt of an IV infusion 7. Positive hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) test at Screening 8. Blood donation within 90 days prior to Day -1 or plasma donation within 1 week prior to Day 1 9. Receipt of specific medications within a specified time period 10. Women who are currently breastfeeding or have a positive pregnancy test

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As listed by the trial registrant

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

Healthy volunteers

Contacts and locations

Locations

  • Celerion

    Lincoln, Nebraska, 68502, United States

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