Phase 1 Study of SL-325 in Healthy Volunteers

Not Applicable

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Biological: SL-325; Other: Placebo (Normal Saline)

• Registration Number: NCT07158437
• Lead Sponsor: Shattuck Labs, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study Start: 2025-09-01
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SAD: SL-325	SL-325	Participants will receive a single dose of SL-325 in escalating dose cohorts
SAD: Placebo	Placebo (Normal Saline)	Participants will receive a single dose of placebo (normal saline)
MAD: SL-325	SL-325	Participants will receive a three doses of SL-325 in escalating dose cohorts
MAD: Placebo	Placebo (Normal Saline)	Participants will receive a three doses of placebo (normal saline)

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	Day 1 through 75 days after last dose	Incidence and severity of treatment-emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Cmax	Day 1 through 75 days after last dose	Maximum observed concentration
Pharmacokinetics (PK): Tmax	Day 1 through 75 days after last dose	Time at which the maximum concentration is observed
Pharmacokinetics (PK): Ctrough	Day 1 through 75 days after last dose	Minimum observed concentration following a single dose
Pharmacokinetics (PK): AUC	Day 1 through 75 days after last dose	Area under the concentration-time curve
Pharmacokinetics (PK): T1/2	Day 1 through 75 days after last dose	Terminal elimination half-life
Pharmacokinetics (PK): CL	Day 1 through 75 days after last dose	Clearance
Pharmacokinetics (PK): Vz	Day 1 through 75 days after last dose	Volume of distribution
Immunogenicity: Number/proportion of participants with positive or negative anti-drug antibody (ADA) titers	Day 1 through 75 days after last dose
Immunogenicity: Number/proportion of participants with neutralizing anti-drug antibodies	Day 1 through 75 days after last dose
Immunogenicity: Time to onset and duration of anti-drug antibodies	Day 1 through 75 days after last dose
Immunogenicity: Number/proportion of participants with transient vs persistent anti-drug antibodies	Day 1 through 75 days after last dose
Receptor Occupancy: Percent of DR3-positive T cells bound by SL-325	Day 1 through 75 days after last dose
Receptor Occupancy: Duration of DR3-positive T cell binding by SL-325	Day 1 through 75 days after last dose

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States