S-892216-LAI: S-892216-LAI injection will be administered per schedule specified in the arm description.
Placebo: Physiological saline will be administered per schedule specified in the arm description.
Study summary
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.
Eligibility
Sex
MALE
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Key Inclusion Criteria:
* Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m\^2)
Key Exclusion Criteria:
* Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (for example, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.
* History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Require medication or other treatment (for example, dietary restrictions or physical therapy).
* Participated in any other clinical study involving an investigational study intervention or any other type of medical research within 30 days, or 5 times the half-life of the investigational drug, before signing of the informed consent form (ICF) for this study or who are currently participating in such a study.
* Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen (HBsAg); hepatitis C virus antibody (HCV); and human immunodeficiency virus (HIV) antigen/antibody.
* Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) test result, positive transcription-mediated amplification test result, positive antigen test result, or any other test approved according to local regulations at check in for each period on admission.
* Known allergy/sensitivity or any hypersensitivity to components of S-892216-LAI or placebo for S-892216-LAI.
* Used cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Primary outcome measure(s)
Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — Day 1 through Day 364
Part 2: Number of Participants With TEAEs — Day 1 through Day 448
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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