Phase 1 Study of SL-325 in Healthy Volunteers

Running, not enrolling · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT07158437

Run by

Shattuck Labs, Inc.

People needed

72

Starts

2025-09-18

Expected to finish

2026-07-01

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provide signed informed consent
• 18-55 years of age, inclusive, at the time of signing the informed consent form
• Body mass index of 18-32 kg/m2, inclusive, and a total body weight > 50 kg
• Laboratory values within normal limits or any abnormalities deemed not clinically significant by the Investigator
• Participant agrees to practice birth control measures

You may not qualify if…

• History or presence of a clinically significant infectious disease or hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, neurologic, or psychiatric abnormality
• Any clinically significant abnormality on vital signs, electrocardiogram (ECG), or laboratory parameters
• History of regular alcohol consumption within 6 months of Screening
• Positive test for use of drugs or alcohol at Screening
• History of use of tobacco- or nicotine-containing products within 3 months of Screening
• History of infusion-related reaction or allergic reaction upon receipt of an IV infusion
• Positive hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) test at Screening
• Blood donation within 90 days prior to Day -1 or plasma donation within 1 week prior to Day 1
• Receipt of specific medications within a specified time period
• Women who are currently breastfeeding or have a positive pregnancy test

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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