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OpenTrials
Active, Not Recruiting

NCT Number: NCT07158437

Phase 1 Study of SL-325 in Healthy Volunteers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

SL-325

Biological

DR3 blocking antibody

Placebo (Normal Saline)

Other

Normal saline

Primary outcomes

  1. Safety and Tolerability

    Time frame: Day 1 through 75 days after last dose

    Incidence and severity of treatment-emergent adverse events

Secondary outcomes

  1. Pharmacokinetics (PK): Cmax

    Time frame: Day 1 through 75 days after last dose

    Maximum observed concentration

  2. Pharmacokinetics (PK): Tmax

    Time frame: Day 1 through 75 days after last dose

    Time at which the maximum concentration is observed

  3. Pharmacokinetics (PK): Ctrough

    Time frame: Day 1 through 75 days after last dose

    Minimum observed concentration following a single dose

  4. Pharmacokinetics (PK): AUC

    Time frame: Day 1 through 75 days after last dose

    Area under the concentration-time curve

  5. Pharmacokinetics (PK): T1/2

    Time frame: Day 1 through 75 days after last dose

    Terminal elimination half-life

  6. Pharmacokinetics (PK): CL

    Time frame: Day 1 through 75 days after last dose

    Clearance

  7. Pharmacokinetics (PK): Vz

    Time frame: Day 1 through 75 days after last dose

    Volume of distribution

  8. Immunogenicity: Number/proportion of participants with positive or negative anti-drug antibody (ADA) titers

    Time frame: Day 1 through 75 days after last dose

  9. Immunogenicity: Number/proportion of participants with neutralizing anti-drug antibodies

    Time frame: Day 1 through 75 days after last dose

  10. Immunogenicity: Time to onset and duration of anti-drug antibodies

    Time frame: Day 1 through 75 days after last dose

  11. Immunogenicity: Number/proportion of participants with transient vs persistent anti-drug antibodies

    Time frame: Day 1 through 75 days after last dose

  12. Receptor Occupancy: Percent of DR3-positive T cells bound by SL-325

    Time frame: Day 1 through 75 days after last dose

  13. Receptor Occupancy: Duration of DR3-positive T cell binding by SL-325

    Time frame: Day 1 through 75 days after last dose

Sponsors and collaborators

Lead sponsor

Shattuck Labs, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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