Phase 1 Study of SL-325 in Healthy Volunteers

Shattuck Labs

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: SL-325; Other: Placebo (Normal Saline)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07158437

SL-325-101

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

SAD: SL-325

Experimental group

Description:

Participants will receive a single dose of SL-325 in escalating dose cohorts

Treatment:

Biological: SL-325

SAD: Placebo

Placebo Comparator group

Description:

Participants will receive a single dose of placebo (normal saline)

Treatment:

Other: Placebo (Normal Saline)

MAD: SL-325

Experimental group

Description:

Participants will receive a three doses of SL-325 in escalating dose cohorts

Treatment:

Biological: SL-325

MAD: Placebo

Placebo Comparator group

Description:

Participants will receive a three doses of placebo (normal saline)

Treatment:

Other: Placebo (Normal Saline)