Overview
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.
Eligibility
Inclusion Criteria:
- Provide signed informed consent
- 18-55 years of age, inclusive, at the time of signing the informed consent form
- Body mass index of 18-32 kg/m2, inclusive, and a total body weight > 50 kg
- Laboratory values within normal limits or any abnormalities deemed not clinically significant by the Investigator
- Participant agrees to practice birth control measures
Exclusion Criteria:
- History or presence of a clinically significant infectious disease or hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, neurologic, or psychiatric abnormality
- Any clinically significant abnormality on vital signs, electrocardiogram (ECG), or laboratory parameters
- History of regular alcohol consumption within 6 months of Screening
- Positive test for use of drugs or alcohol at Screening
- History of use of tobacco- or nicotine-containing products within 3 months of Screening
- History of infusion-related reaction or allergic reaction upon receipt of an IV infusion
- Positive hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) test at Screening
- Blood donation within 90 days prior to Day -1 or plasma donation within 1 week prior to Day 1
- Receipt of specific medications within a specified time period
- Women who are currently breastfeeding or have a positive pregnancy test