Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
Purpose
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.
Condition
- Healthy Participants
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m^2)
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1 (Single Ascending Dose) |
Participants will receive a single dose of S-892216-LAI or placebo on Day 1. |
|
|
Experimental Part 2 (Multiple Ascending Dose) |
Participants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively. |
|
Recruiting Locations
ICON Clinical Research: Lenexa
Lenexa 4274356, Kansas 4273857 66219
Lenexa 4274356, Kansas 4273857 66219
ICON Clinical Research: Salt Lake City
Salt Lake City 5780993, Utah 5549030 84124
Salt Lake City 5780993, Utah 5549030 84124
More Details
- NCT ID
- NCT07093580
- Status
- Recruiting
- Sponsor
- Shionogi
Study Contact
Shionogi Clinical Trials Administrator Clinical Support Help Line800-849-9707
Shionogiclintrials-admin@shionogi.co.jp