Healthy Volunteers
Conditions
Keywords
DR3, SL-325
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.
Interventions
BIOLOGICALSL-325
DR3 blocking antibody
OTHERPlacebo (Normal Saline)
Normal saline
Sponsors
Shattuck Labs, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Day 1 through 75 days after last dose | Incidence and severity of treatment-emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Cmax | Day 1 through 75 days after last dose | Maximum observed concentration |
| Pharmacokinetics (PK): Tmax | Day 1 through 75 days after last dose | Time at which the maximum concentration is observed |
| Pharmacokinetics (PK): Ctrough | Day 1 through 75 days after last dose | Minimum observed concentration following a single dose |
| Pharmacokinetics (PK): AUC | Day 1 through 75 days after last dose | Area under the concentration-time curve |
| Pharmacokinetics (PK): T1/2 | Day 1 through 75 days after last dose | Terminal elimination half-life |
| Pharmacokinetics (PK): CL | Day 1 through 75 days after last dose | Clearance |
| Pharmacokinetics (PK): Vz | Day 1 through 75 days after last dose | Volume of distribution |
| Immunogenicity: Number/proportion of participants with positive or negative anti-drug antibody (ADA) titers | Day 1 through 75 days after last dose | — |
| Immunogenicity: Number/proportion of participants with neutralizing anti-drug antibodies | Day 1 through 75 days after last dose | — |
| Immunogenicity: Time to onset and duration of anti-drug antibodies | Day 1 through 75 days after last dose | — |
| Immunogenicity: Number/proportion of participants with transient vs persistent anti-drug antibodies | Day 1 through 75 days after last dose | — |
| Receptor Occupancy: Percent of DR3-positive T cells bound by SL-325 | Day 1 through 75 days after last dose | — |
| Receptor Occupancy: Duration of DR3-positive T cell binding by SL-325 | Day 1 through 75 days after last dose | — |
Countries
United States
Outcome results
None listed