SL-325 for Healthy Volunteers

Overseen By Study Director

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Shattuck Labs, Inc.

Disqualifiers: Infectious disease, Cardiovascular, Neurologic, others

Compensation: Varies

Number of Visits: Unknown

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SL-325 to understand its safety and how the body processes it. In its early stages, the study involves giving healthy volunteers either a single dose or three doses of SL-325 or a placebo (a substance with no active drug) to observe any side effects. It suits those who are generally healthy, do not use tobacco or alcohol regularly, and are willing to avoid pregnancy during participation. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

Will I have to stop taking my current medications?

The trial information does not clearly state if you need to stop taking your current medications, but it mentions that certain medications must not be taken within a specific time period before the trial. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that SL-325 is likely to be safe for humans?

Research has shown that SL-325 looks promising in early lab studies. These tests found no harmful effects, indicating the treatment seemed safe in the lab. This upcoming study will be the first time SL-325 is tested in humans, focusing primarily on its safety for people. Although results from human trials are not yet available, the lab results are encouraging. They suggest that SL-325 might be safe for people, but human trials will provide clearer answers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SL-325 is unique because it introduces a new approach by potentially offering a faster onset of action compared to current treatments. Unlike traditional options that often require prolonged usage, SL-325 could deliver noticeable effects more quickly due to its innovative formulation and mechanism of action. Researchers are particularly excited about its ability to be administered in escalating doses, which might enhance its effectiveness and tailor it better to individual needs. This could lead to more personalized and efficient treatment strategies.

What evidence suggests that SL-325 could be effective?

Research has shown that SL-325 blocks certain proteins that cause inflammation, potentially helping treat conditions like Inflammatory Bowel Disease (IBD). Early studies suggest SL-325 might offer a new and unique way to manage inflammation. Initial lab tests have been promising, indicating potential effectiveness for these conditions. However, limited information from human studies means more research is needed to confirm these results. In this trial, participants will receive either a single or multiple doses of SL-325 or a placebo to further evaluate its effects and safety in healthy volunteers. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy volunteers who want to participate in a study testing a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conflicting conditions or medications.

Inclusion Criteria

Provide signed informed consent

Laboratory values within normal limits or any abnormalities deemed not clinically significant by the Investigator

My BMI is between 18-32 and I weigh more than 50 kg.

Exclusion Criteria

Clinically significant abnormality on vital signs, ECG, or laboratory parameters

History of regular alcohol consumption within 6 months of Screening

Positive test for use of drugs or alcohol at Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single-Ascending Dose (SAD) Treatment

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

1 week

Multiple-Ascending Dose (MAD) Treatment

Participants receive three doses of SL-325 or placebo in escalating dose cohorts

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

75 days

What Are the Treatments Tested in This Trial?

Interventions

• SL-325

Trial Overview The trial is testing SL-325 against a placebo (normal saline). It's the first time this drug is being tested in humans. The study will gradually increase doses to see how much can be taken safely.

How Is the Trial Designed?

Group I: SAD: SL-325 Experimental Treatment 1 Intervention

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

Group II: MAD: SL-325 Experimental Treatment 1 Intervention

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

Group III: SAD: Placebo Placebo Group 1 Intervention

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

Group IV: MAD: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Shattuck Labs, Inc.

Lead Sponsor

Trials

5

Recruited

270+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07158437

Phase 1 Study of SL-325 in Healthy Volunteers In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment.

2. ir.shattucklabs.com ir.shattucklabs.com/investors/news-events/press-releases/news-details/2025/Shattuck-Labs-Announces-IND-for-SL-325-Is-in-Effect-for-the-Treatment-of-Inflammatory-Bowel-Disease/default.aspx

Shattuck Labs Announces IND for SL-325 Is in Effect ... SL-325 is a potentially first-in-class DR3 antagonist antibody being developed for the treatment of Inflammatory Bowel Disease (IBD) and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07158437?rank=7

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 ...

4. q4live.s205.clientfiles.s3-website-us-east-1.amazonaws.com q4live.s205.clientfiles.s3-website-us-east-1.amazonaws.com/862988904/files/doc_events/2025/Feb/20/Shattuck-Labs-STTK-_European-Crohn-s-and-Colitis-Organization-ECCO-_VF.pdf

Preclinical Development of SL-325, a High Affinity DR3 ... Projected Dose and Schedule in Human Subjects. This slide shows preliminary data and analysis available to Shattuck as of the February 6, 2025.

5. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-8-2025-324e0

SL-325 for 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 ...

6. finance.yahoo.com finance.yahoo.com/news/shattuck-labs-announces-ind-sl-141700145.html

Shattuck Labs Announces IND for SL-325 Is in Effect ... Shattuck expects to commence a Phase 1 clinical trial in healthy volunteers in the third quarter of 2025. STORY_CONTINUES.

7. globenewswire.com globenewswire.com/news-release/2025/02/20/3029722/0/en/Shattuck-Labs-Announces-Positive-Data-from-the-Preclinical-GLP-Toxicology-Study-of-SL-325-at-the-20th-Congress-of-European-Crohn-s-and-Colitis-Organization-ECCO-in-Inflammatory-Bow.html

Shattuck Labs Announces Positive Data from the Preclinical Results from this preclinical study indicate that SL-325 is a high-affinity DR3 blocking antibody with no evidence of toxicity or residual ...