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

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
Shionogi
Study ID
NCT07093580
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • S-892216-LAI — DRUG
    S-892216-LAI injection will be administered per schedule specified in the arm description.
  • Placebo — DRUG
    Physiological saline will be administered per schedule specified in the arm description.

Study Details

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.

Key Dates

Start date
Jul 29, 2025
Status verified
Aug 2025
Primary completion
May 26, 2027
Completion
May 26, 2027

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 through Day 364 ]

Central Contacts

  • Shionogi Clinical Trials Administrator Clinical Support Help Line
    800-849-9707
    [email protected]

Locations (2)

FacilityCityStateZIPSite coordinators
ICON Clinical Research: LenexaLenexaKansas66219-
ICON Clinical Research: Salt Lake CitySalt Lake CityUtah84124-

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By research site
ICON Clinical Research: Lenexa· Lenexa, KSICON Clinical Research: Salt Lake City· Salt Lake City, UT

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