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

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Shionogi

Status and phase

Not yet enrolling
Phase 1

Conditions

Healthy Participants

Treatments

Drug: Placebo
Drug: S-892216-LAI

Study type

Interventional

Funder types

Industry

Identifiers

NCT07093580
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

98 estimated patients

Sex

Male

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

98 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

Trial contacts and locations

2

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Central trial contact

Shionogi Clinical Trials Administrator Clinical Support Help Line

Data sourced from clinicaltrials.gov

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