Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Subcutaneous Injection of Denosumab.

A Randomized, Single-dose, Single-center, Comparative Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Subcutaneous Injection of Denosumab (Hetero) and Reference Medicinal Product (Denosumab, Amgen Inc.) in Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030382

Enrollment

130

Registered

2021-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Denosumab, Solution for injection, 70 mg/ml: administered as a single subcutaneous injection Administer Denosumab via subcutaneous injection in the upper arm, the upper thigh, or the ab

Eligibility

Inclusion criteria

Inclusion criteria: 1 Subjects willing to give Informed Consent. 2 Healthy adult subjects within 18-65 years of age (inclusive). 3 Subject with Body Mass Index (BMI) having range between 18.0 and 25.0 (both inclusive), calculated as weight in Kg and height in m2. 4 Ability to comply with study and follow-up procedures and provide written informed consent 5 Subjects 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.

Exclusion criteria

Exclusion criteria: 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] 2 Presents with any psychiatric disorder, which may prevent the subject from completing the study or interfere with the interpretation of the study results 3 Significant changes in physical activity during the 6 months before study drug administration or constant levels of intense physical exercise

Design outcomes

Primary

Measure	Time frame
Maximum Observed Drug Concentration (Cmax) of DenosumabTimepoint: Time Frame: Day 1 predose up to week 19	—

Secondary

Measure	Time frame
Area Under the Drug Concentration-time CurveTimepoint: From Time 0 to infinity Post-dose (AUC0-inf) of Denosumab;Time to Maximum Observed Concentration (Tmax) of DenosumabTimepoint: Time Frame: Day 1 predose up to week 19	—

Countries

India

Contacts

Public ContactDr S Sadgune

Mudra Clincare

dr.sayalitarte@gmail.com

Outcome results