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Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants

NCT07093580 · Shionogi Inc.
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Official title
Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants
About this study
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 criteria
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.
Study design
Enrollment target: 98 participants
Allocation: randomized
Masking: quadruple
Age groups: adult
Timeline
Starts: 2025-07-29
Estimated completion: 2027-05-26
Last updated: 2025-08-27
Interventions
Drug: S-892216-LAIDrug: Placebo
Primary outcomes
  • 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)
Sponsor
Shionogi · industry
Contacts & investigators
ContactShionogi Clinical Trials Administrator Clinical Support Help Line · contact · Shionogiclintrials-admin@shionogi.co.jp · 800-849-9707
All locations (2)
ICON Clinical Research: LenexaRecruiting
Lenexa, Kansas, United States
ICON Clinical Research: Salt Lake CityRecruiting
Salt Lake City, Utah, United States
Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants · TrialPath