Status:
RECRUITING
Phase 1 Study of SL-325 in Healthy Volunteers
Lead Sponsor:
Shattuck Labs, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07158437
Start Date
September 1 2025
End Date
July 1 2026
Last Update
September 5 2025
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502