NCT07158437

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
2mo left

Started Sep 2025

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

August 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

September 18, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

August 28, 2025

Last Update Submit

April 29, 2026

Conditions

Healthy Volunteers

Keywords

DR3SL-325

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    Incidence and severity of treatment-emergent adverse events

    Day 1 through 75 days after last dose

Secondary Outcomes (13)

  • Pharmacokinetics (PK): Cmax

    Day 1 through 75 days after last dose

  • Pharmacokinetics (PK): Tmax

    Day 1 through 75 days after last dose

  • Pharmacokinetics (PK): Ctrough

    Day 1 through 75 days after last dose

  • Pharmacokinetics (PK): AUC

    Day 1 through 75 days after last dose

  • Pharmacokinetics (PK): T1/2

    Day 1 through 75 days after last dose

  • +8 more secondary outcomes

Study Arms (4)

SAD: SL-325

EXPERIMENTAL

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

Biological: SL-325

SAD: Placebo

PLACEBO COMPARATOR

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

Other: Placebo (Normal Saline)

MAD: SL-325

EXPERIMENTAL

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

Biological: SL-325

MAD: Placebo

PLACEBO COMPARATOR

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

Other: Placebo (Normal Saline)

Interventions

SL-325BIOLOGICAL

DR3 blocking antibody

MAD: SL-325SAD: SL-325
Placebo (Normal Saline)OTHER

Normal saline

MAD: PlaceboSAD: Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provide signed informed consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

3-(2-(4-quinolin-3-yl)benzyl-1-oxoisoindolin-6-yl)-N-hydroxy-acrylamideSaline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 5, 2025

Study Start

September 18, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)