Phase 1 Study of SL-325 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled Single-Ascending Dose and Multiple-Ascending Dose 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 in healthy volunteers.

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