Phase 1: testing S-892216-LAI for Healthy Participants
This study wants to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.
Official registry: https://clinicaltrials.gov/study/NCT07093580 · Shionogi · enrollment listed as 128
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are S-892216-LAI, or Placebo. The registry lists allocation as randomized. This study wants to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.
They plan to enroll about 128 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants
Interventions: S-892216-LAI, Placebo
Primary outcome (registry wording): Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Who it is for (from inclusion criteria)
- Ages 18 Years to 55 Years
- Body mass index (body-mass index (BMI)) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m\^2)
Who the registry excludes
- 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)
- 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
- Known allergy/sensitivity or any hypersensitivity to components of S-892216-LAI or dummy treatment (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/
Public study contact (from the registry)
Shionogi Clinical Trials Administrator Clinical Support Help Line
Shionogiclintrials-admin@shionogi.co.jp
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
3 listed- Altasciences — Cypress, California (recruiting)
- ICON Clinical Research: Lenexa — Lenexa, Kansas (active_not_recruiting)
- ICON Clinical Research: Salt Lake City — Salt Lake City, Utah (active_not_recruiting)
FAQ about this NCT record
Is NCT07093580 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07093580?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07093580?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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