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

NCT07093580 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2316T1711
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Participants

Keywords

First-in-human (FIH); Long-acting injectable (LAI) formulation; S-892216; S-892216-LAI; Severe acute respiratory syndrome coronavirus 2; SARS-CoV-2 infection; Novel Coronavirus; Coronavirus Disease 2019; COVID-19

Outcome Measures

Primary Outcomes (2)

• Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Day 1 through Day 364

• Part 2: Number of Participants With TEAEs

  Day 1 through Day 448

Secondary Outcomes (6)

• Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites

  Day 1 (pre-administration, up to 12 hours post-administration) through Day 364

• Part 2: Cmax of S-892216 and its Metabolites

  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

  Day 1 (pre-administration, up to 12 hours post-administration) through Day 364

• Part 2: Tmax of S-892216 and its Metabolites

  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

  Day 1 (pre-administration, up to 12 hours post-administration) through Day 364

Study Arms (2)

Part 1 (Single Ascending Dose)

EXPERIMENTAL

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

Drug: S-892216-LAI; Drug: Placebo

Part 2 (Multiple Ascending Dose)

EXPERIMENTAL

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; Drug: Placebo

Interventions

S-892216-LAI DRUG

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

Part 1 (Single Ascending Dose); Part 2 (Multiple Ascending Dose)

Placebo DRUG

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

Part 1 (Single Ascending Dose); Part 2 (Multiple Ascending Dose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m\^2)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (2)

ICON Clinical Research: Lenexa

Lenexa, Kansas, 66219, United States

RECRUITING

ICON Clinical Research: Salt Lake City

Salt Lake City, Utah, 84124, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

800-849-9707; Shionogiclintrials-admin@shionogi.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): May 26, 2027
• Study Completion (Estimated): May 26, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (2)