None listed
Conditions
Interventions
Intervention1: Lupins Denosumab: Denosumab 60 mg solution for injection (60 mg/mL) in pre-filled syringe.
Total treatment duration would be 128 days with single dose.
Control Intervention1: Comparator
Sponsors
Lupin Limited (Research Park)
Eligibility
Inclusion criteria
Inclusion criteria: BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5) Able to communicate effectively with study personnel. Willing to provide written informed consent to participate in the study. All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include: a) A physical examination (clinical examination) with no clinically significant finding. b) Results within normal limits or clinically non-significant for the following tests: 1. Hematology test 2. Biochemistry test 3. Urinalysis 4. Immunological Tests 5. Additional tests Additional tests and/or examinations (apart from mentioned in protocol) may be performed, if necessary, based on principal investigator discretion. All results will be assessed against the current laboratory normal ranges at the time of testing and a copy of the normal ranges used will be included in the study documentation.
Exclusion criteria
Exclusion criteria: Volunteers must not be enrolled in the study if they meet any one of the following criteria: 1) History of allergic responses to Denosumab or other related drugs, or any of its formulation ingredients. 2) Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG, chest X-ray recording, Ankle Brachial Index test]. 3) Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system. 4) History or presence of bronchial asthma. 5) Use of any hormone replacement therapy within 3 months prior to study medication administration. 6) Use of any depot injection or implant of any drug within 3 months prior to study medication administration. 7) Use of CYP enzyme inhibitors or inducers within 30 days prior to study medication administration (see https://drug-interactions.medicine.iu.edu/MainTable.aspx). 8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use. 9) Smokers who smoke 10 or more cigarettes/e-cigarettes per day or 20 or more biddies per day or those who cannot refrain from smoking during the study period. 10) History of difficulty with donating blood or difficulty in accessibility of veins. 11) A positive hepatitis screen (includes subtypes B & C). 12) A positive test result for HIV antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparitive pharmacokinetic and pharmacodynamicTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Presence of anti-drug antibodies (ADA) and the neutralizing antibodies (NAb) will be determined.Timepoint: 3,6,9,12 months | — |
Countries
India
Contacts
Public ContactDr Suhas Khandare
Lupin Limited
Outcome results
None listed