Healthy Participants
Conditions
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
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.
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.
Sponsors
Shionogi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 through Day 364 |
| Part 2: Number of Participants With TEAEs | Day 1 through Day 448 |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites | Day 1 (pre-administration, up to 12 hours post-administration) through Day 364 |
| Part 2: Tmax of S-892216 and its Metabolites | 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 |
| Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites | Day 1 (pre-administration, up to 12 hours post-administration) through Day 364 |
| Part 2: AUC0-last of S-892216 and its Metabolites | 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 |
| 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 | Day 1 (pre-administration, up to 12 hours post-administration) through Day 364 |
| Part 2: Cmax of S-892216 and its Metabolites | 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 |
Countries
United States
Contacts
Primary ContactShionogi Clinical Trials Administrator Clinical Support Help Line
Outcome results
None listed