NCT07093580 Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
| NCT ID | NCT07093580 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shionogi |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2025-07-29 |
| Primary Completion | 2027-05-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 98 participants in total. It began in 2025-07-29 with a primary completion date of 2027-05-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Shionogi Clinical Trials Administrator Clinical Support Help Line
✉ Shionogiclintrials-admin@shionogi.co.jp📞 800-849-9707
Frequently Asked Questions
Who can join the NCT07093580 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 55 Years, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07093580 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07093580 currently recruiting?
Yes, NCT07093580 is actively recruiting participants. Contact the research team at Shionogiclintrials-admin@shionogi.co.jp for enrollment information.
Where is the NCT07093580 trial being conducted?
This trial is being conducted at Lenexa, United States, Salt Lake City, United States.
Who is sponsoring the NCT07093580 clinical trial?
NCT07093580 is sponsored by Shionogi. The trial plans to enroll 98 participants.