RECRUITING

Phase 1 Study of SL-325 in Healthy Volunteers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07158437

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Study Director

CONTACT

919-864-2700

clinicaltrials@shattucklabs.com

Study Locations (Sites)

Celerion

Lincoln, Nebraska, 68502

United States

Collaborators and Investigators

Sponsor: Shattuck Labs, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09

Study Completion Date2026-07

Study Record Updates

Study Start Date2025-09

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

DR3
SL-325

Additional Relevant MeSH Terms

Healthy Volunteers