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

August 20, 2025 updated by: Shionogi

Phase 1 Study of a Long-acting Injectable S-892216 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Recruiting
        • ICON Clinical Research: Lenexa
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Recruiting
        • ICON Clinical Research: Salt Lake City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 through Day 364
Day 1 through Day 364
Part 2: Number of Participants With TEAEs
Time Frame: Day 1 through Day 448
Day 1 through Day 448

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
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
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
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
Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
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
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
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
Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shionogi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2025

Primary Completion (Estimated)

May 26, 2027

Study Completion (Estimated)

May 26, 2027

Study Registration Dates

First Submitted

July 23, 2025

First Submitted That Met QC Criteria

July 23, 2025

First Posted (Actual)

July 30, 2025

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2316T1711

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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