Healthy Adult Males
Conditions
Interventions
A subcutaneous injection of 1.7 mL of either IRO2201A 120 mg vial(120 mg/1.7mL) or RANMARK R Subcutaneous Injection 120 mg(120 mg/1.7 mL)will be administered into the abdominal region.
Sponsors
Hibino Toshihiko
Eligibility
Inclusion criteria
Inclusion criteria: (1) Japanese males residing in Japan, aged 25 years or older and under 45 years at the time of consent. (2) Individuals who have received a prior explanation of the clinical trial, are able to understand its contents, and can provide written informed consent personally. (3)Individuals whose Body Mass Index (BMI) is 18.5 kg/m2 or higher and less than 25 kg/m2, based on results from the screening test and the examination conducted the day before administration. (4) Individuals who are judged eligible by the investigator based on medical history and test results during the screening examination. (5) Individuals who can comply with the requirements during the trial, undergo scheduled medical examinations and tests as defined in the clinical trial protocol, and report subjective symptoms. (6) Individuals who can follow instructions given by the medical institution staff.
Exclusion criteria
Exclusion criteria: (1) Individuals with hypocalcemia or a history of hypocalcemia at the time of screening. (2) Individuals with clinically significant gastrointestinal, respiratory, or cardiovascular diseases at screening (excluding conditions such as appendicitis). (3) Individuals with clinically significant hepatic or renal dysfunction at screening. (4) Individuals with diabetes mellitus. (5) Individuals with a history of major gastrointestinal surgery, such as gastrectomy, intestinal anastomosis, or bowel resection (excluding appendicitis). (6) Individuals with a hypersensitivity to drugs. (7) Individuals with alcohol or drug dependence, or a history thereof, at screening. (8) Individuals who test positive for HBs antigen, HCV antibody, HIV antigen/antibody, or syphilis at screening. (9) Individuals with hypersensitivity to recombinant glycoproteins or any component of the investigational drug. (10) Individuals who have participated in another clinical trial and received an investigational drug within 16 weeks prior to administration (or 12 weeks in the case of a generic drug trial). (11) Individuals who have used prescription drugs or OTC medications within 28 days, or vitamin supplements within 7 days prior to administration, or who require such medications during the trial period. (12) Individuals who have donated 400 mL of whole blood within 12 weeks, 200 mL within 4 weeks, or blood components (plasma or platelets) within 2 weeks prior to administration. (13) Individuals who have consumed alcohol within 48 hours before screening; consumed caffeine-rich foods or smoked within 48 hours before screening; or are unable to abstain from caffeine and smoking from 24 hours before hospitalization until discharge. (14) Individuals who are undergoing invasive dental procedures such as tooth extraction; those with periodontal disease, apical lesions, osteonecrosis of the jaw, ill-fitting dentures, or poor oral hygiene. (15) Individuals with a history of denosumab administration. (16) Any other individuals deemed ineligible for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Evaluation Parameters Area Under the Serum Drug Concentration - Time Curve(AUC0-t) Maximum Serum Drug Concentration(Cmax) | — |
Contacts
Public ContactToshihiko Hibino
ID Pharma Co. Ltd.
Outcome results
None listed