Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Subcutaneous Injection of Denosumab.
- Registration Number
- CTRI/2021/01/030382
- Lead Sponsor
- PSK Pharma LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1Subjects willing to give Informed Consent.
2Healthy adult subjects within 18-65 years of age (inclusive).
3Subject with Body Mass Index (BMI) having range between 18.0 and 25.0 (both inclusive), calculated as weight in Kg and height in m2.
4Ability to comply with study and follow-up procedures and provide written informed consent
5Subjects who have no evidence of underlying disease during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study.
1 Prior diagnosis of bone disease, or any condition that will affect bone metabolism such as, but not limited to: osteoporosis, osteogenesis imperfecta, hyperparathyroidism, hyperthyroidism, hypothyroidism, osteomalacia, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout, active malignancy, renal disease (defined as glomerular filtration rate [GFR] < 45 mL/min), Pagets disease of the bone, recent bone fracture (within 6 months), malabsorption syndrome
2Presents with any psychiatric disorder, which may prevent the subject from completing the study or interfere with the interpretation of the study results
3Significant changes in physical activity during the 6 months before study drug administration or constant levels of intense physical exercise
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method