Phase 1 Study of SL-325 in Healthy Volunteers

NCT ID: NCT07158437

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAD: SL-325

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

Group Type EXPERIMENTAL

SL-325

Intervention Type BIOLOGICAL

DR3 blocking antibody

SAD: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo (Normal Saline)

Intervention Type OTHER

Normal saline

MAD: SL-325

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

Group Type EXPERIMENTAL

SL-325

Intervention Type BIOLOGICAL

DR3 blocking antibody

MAD: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo (Normal Saline)

Intervention Type OTHER

Normal saline

Interventions

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SL-325

DR3 blocking antibody

Intervention Type BIOLOGICAL

Placebo (Normal Saline)

Normal saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shattuck Labs, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Celerion

Lincoln, Nebraska, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Study Director

Role: CONTACT

919-864-2700

Other Identifiers

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SL-325-101

Identifier Type: -

Identifier Source: org_study_id

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