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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-29

Study Completion Date

2027-05-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1 (Single Ascending Dose)

Participants will receive a single dose of S-892216-LAI or placebo on Day 1.

Group Type EXPERIMENTAL

S-892216-LAI

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

S-892216-LAI

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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S-892216-LAI

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes