Recruiting
Phase 1

S-892216-LAI

Sponsor:

Shionogi

Code:

NCT07093580

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

S-892216-LAI

Placebo

Study Details

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

Study ID

NCT07093580

Start date

Jul 29, 2025

Status verified date

Oct, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 (Single Ascending Dose)

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

experimental: 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.

Interventions

S-892216-LAI

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

Placebo

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

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

Locations

Altasciences

Recruiting

Cypress, California, United States, 90630

More Information

Sponsor

Shionogi

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Shionogi on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.