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NCT Number: NCT07093580

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

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.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ICON Clinical Research: Lenexa, Lenexa, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S-892216-LAI

Drug

S-892216-LAI injection will be administered per schedule specified in the arm description.

Placebo

Drug

Physiological saline will be administered per schedule specified in the arm description.

Primary outcomes

  1. Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Day 1 through Day 364

  2. Part 2: Number of Participants With TEAEs

    Time frame: Day 1 through Day 448

Secondary outcomes

  1. Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites

    Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364

  2. Part 2: Cmax of S-892216 and its Metabolites

    Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2

  3. Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites

    Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364

  4. Part 2: Tmax of S-892216 and its Metabolites

    Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2

  5. Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216 and its Metabolites

    Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364

  6. Part 2: AUC0-last of S-892216 and its Metabolites

    Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2

Study contacts

Contact information is provided by the study sponsor or research team.

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

[email protected]

800-849-9707

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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