RecruitingPhase 1NCT07158437

Phase 1 Study of SL-325 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled Single-Ascending Dose and Multiple-Ascending Dose Phase 1 Study of SL-325 in Healthy Volunteers

Sponsor

Shattuck Labs, Inc.

Enrollment

72 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers

Summary

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria5

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

Exclusion Criteria10

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