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

ArmDescriptionAssigned Intervention
Experimental
Part 1 (Single Ascending Dose) 		Participants will receive a single dose of S-892216-LAI or placebo on Day 1.
  • Drug: S-892216-LAI
    S-892216-LAI injection will be administered per schedule specified in the arm description.
  • Drug: Placebo
    Physiological saline will be administered per schedule specified in the arm description.
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.
  • Drug: S-892216-LAI
    S-892216-LAI injection will be administered per schedule specified in the arm description.
  • Drug: Placebo
    Physiological saline will be administered per schedule specified in the arm description.

Recruiting Locations

ICON Clinical Research: Lenexa
Lenexa 4274356, Kansas 4273857 66219

ICON Clinical Research: Salt Lake City
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 Line
800-849-9707
Shionogiclintrials-admin@shionogi.co.jp