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Recruiting NCT07093580

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

Phase I Interventional Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: S-892216-LAI, Placebo.
Who it may be relevant to
Registry conditions: Healthy Participants. Basic parameters: 18 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Time frame: Day 1 through Day 364]
  • Part 2: Number of Participants With TEAEs [Time frame: Day 1 through Day 448]
Secondary outcome measures (6)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • ICON Clinical Research: Lenexa — Lenexa
  • ICON Clinical Research: Salt Lake City — Salt Lake City

Identifiers

NCT: NCT07093580 · 2316T1711

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗