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RecruitingAccepts healthy volunteersPhase 1

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

Shionogi · NCT07093580

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
128
US sites recruiting
1
Study start
July 29, 2025
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: S-892216-LAI; Placebo

Conditions: Healthy Participants

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Shionogi Clinical Trials Administrator Clinical Support Help Line · 800-849-9707 · Shionogiclintrials-admin@shionogi.co.jp
Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult… (NCT07093580) | Bored Studies