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

Shionogi

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: S-892216-LAI; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07093580

RRPV-24-03-SmMol-001 (Other Grant/Funding Number)

2316T1711

Details and patient eligibility

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups

Part 1 (Single Ascending Dose)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: S-892216-LAI

Part 2 (Multiple Ascending Dose)

Experimental group

Description:

Participants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively.

Treatment:

Drug: Placebo

Drug: S-892216-LAI