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Phase 1 Study of SL-325 in Healthy Volunteers

Phase 1 Study of SL-325 in Healthy Volunteers

Recruiting
18-55 years
All
Phase 1

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Overview

This first-in-human study is a randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose study of SL-325 in healthy volunteers.

Eligibility

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

Study details
    Healthy Volunteers

NCT07158437

Shattuck Labs, Inc.

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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