The purpose of this study is to investigate the safety, tolerability, andpharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI inhealthy adults.
Not Provided
Drug: S-892216-LAI
S-892216-LAI injection will be administered per schedule specified in the arm
description.
Drug: Placebo
S-892216-LAI matching placebo injection will be administered per schedule specified in
the arm description.
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.
ICON Clinical Research: Lenexa
Lenexa, Kansas, United States
ICON Clinical Research: Salt Lake City
Salt Lake City, Utah, United States
Shionogi Clinical Trials Administrator Clinical Support Help Line
800-849-9707
Shionogiclintrials-admin@shionogi.co.jp
Not Provided