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RecruitingNCT07093580Updated Oct 6, 2026

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

A Phase 1 interventional study of S-892216-LAI and Placebo in Healthy Participants, sponsored by Shionogi. Recruiting at 2 sites in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Shionogi · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Updated Oct 6, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Participants

Browse trials for

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
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 98 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Shionogi is the lead sponsor of 104 studies on the registry; 10 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 21 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility 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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
98 participants (estimated)

Study arms

  • Experimental
    Part 1 (Single Ascending Dose)

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

    Drug: S-892216-LAI · Drug: Placebo

  • 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.

    Drug: S-892216-LAI · Drug: Placebo

Interventions

  • DrugS-892216-LAI

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

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

    Time frame: Day 1 through Day 364

  2. Part 2: Number of Participants With TEAEs

    Time frame: Day 1 through Day 448

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

07

Study locations

2 of 2 sites recruiting
  • ICON Clinical Research: Lenexa
    Lenexa, Kansas 66219, United States
    Recruiting
  • ICON Clinical Research: Salt Lake City
    Salt Lake City, Utah 84124, United States
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Primary completion
May 26, 2027→Jun 30, 2028
Oct 6, 2026
Study completion
May 26, 2027→Jun 30, 2028
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Primary completion May 26, 2027→Jun 30, 2028
    Study completion May 26, 2027→Jun 30, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07093580
Lead sponsor
Shionogi
Responsible party
Sponsor
First posted
Jul 30, 2025
Start date
Jul 29, 2025
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Oct 6, 2026

Study contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line
Contact
Shionogiclintrials-admin@shionogi.co.jp
800-849-9707

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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