S-892216 long-acting injectable for healthy adults

Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants

This trial will test single and multiple doses of the long-acting injectable S-892216 for safety and to see how the body processes it in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years to 55 Years
• Sex: Male
• Sponsor: Shionogi Inc. (Industry-sponsored)
• Locations: 2 sites (Lenexa, Kansas and 1 other locations)
• Trial ID: NCT07093580 on ClinicalTrials.gov

What this trial studies

This first-in-human Phase 1 interventional trial administers single and multiple doses of S-892216-LAI versus placebo in healthy adult volunteers to characterize safety, tolerability, and pharmacokinetics. Participants will receive intramuscular injections and undergo scheduled clinical exams, laboratory testing, and blood sampling to measure drug levels over time. Adverse events and tolerability signals will be recorded and used to guide future dosing and development decisions. The study is conducted at ICON Clinical Research sites in Lenexa, Kansas and Salt Lake City, Utah.

Who should consider this trial

Good fit: Ideal candidates are healthy adults with a BMI between 18.5 and 32.0 kg/m^2 who have no significant medical conditions and can attend visits at the Lenexa, KS or Salt Lake City, UT sites.

Not a fit: People with significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological disorders, active cancer, or those requiring regular medications are unlikely to be eligible and would not be expected to benefit from participation.

Why it matters

Potential benefit: If successful, the long-acting injectable could allow less frequent dosing and potentially extend protection or treatment duration compared with shorter-acting options.

How similar studies have performed: This is a first-in-human trial for S-892216-LAI, although long-acting injectable formulations and long-acting monoclonal approaches have been used successfully in other infectious disease contexts.

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.

Where this trial is running

Lenexa, Kansas and 1 other locations

• ICON Clinical Research: Lenexa — Lenexa, Kansas, United States (Recruiting)
• ICON Clinical Research: Salt Lake City — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Shionogi Clinical Trials Administrator Clinical Support Help Line

Conditions Healthy Participants; First-in-human; Long-acting injectable formulation; S-892216; S-892216-LAI; Severe acute respiratory syndrome coronavirus 2; SARS-CoV-2 infection; Novel Coronavirus