Study Results
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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RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2025-09-30
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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SAD: SL-325
Participants will receive a single dose of SL-325 in escalating dose cohorts
SL-325
DR3 blocking antibody
SAD: Placebo
Participants will receive a single dose of placebo (normal saline)
Placebo (Normal Saline)
Normal saline
MAD: SL-325
Participants will receive a three doses of SL-325 in escalating dose cohorts
SL-325
DR3 blocking antibody
MAD: Placebo
Participants will receive a three doses of placebo (normal saline)
Placebo (Normal Saline)
Normal saline
Interventions
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SL-325
DR3 blocking antibody
Placebo (Normal Saline)
Normal saline
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
55 Years
ALL
Yes
Sponsors
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Shattuck Labs, Inc.
INDUSTRY
Responsible Party
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Locations
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Celerion
Lincoln, Nebraska, United States
Countries
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Central Contacts
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Other Identifiers
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SL-325-101
Identifier Type: -
Identifier Source: org_study_id
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