Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants
ConditionHealthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorShionogi
About this trial
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
This trial accepts healthy volunteersQualifiers
Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m²)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
S-892216-LAI
DrugS-892216-LAI injection will be administered per schedule specified in the arm description.
Placebo
DrugPhysiological saline will be administered per schedule specified in the arm description.
Treatment groups
98 Participants
are divided into 2 treatment groupsGroup A: Part 1 (Single Ascending Dose)Experimental treatment 2 interventions
Group B: Part 2 (Multiple Ascending Dose)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame
Day 1 through Day 3642
Part 2: Number of Participants With TEAEs
Time frame
Day 1 through Day 448Secondary outcomes
1
Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites
Time frame
Day 1 (pre-administration, up to 12 hours post-administration) through Day 3642
Part 2: Cmax of S-892216 and its Metabolites
Time frame
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 23
Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites
Time frame
Day 1 (pre-administration, up to 12 hours post-administration) through Day 3644
Part 2: Tmax of S-892216 and its Metabolites
Time frame
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 Source ClinicalTrials.gov