Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants (NCT07093580) | Clinical Trial Compass
RecruitingPhase 1
Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
United States98 participantsStarted 2025-07-29
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexMALE
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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 r…
What they're measuring
1
Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: Day 1 through Day 364
2
Part 2: Number of Participants With TEAEs
Timeframe: Day 1 through Day 448
Trial details
NCT IDNCT07093580
SponsorShionogi
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-05-26
Contact for this trial
Shionogi Clinical Trials Administrator Clinical Support Help Line