Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

• Status: Not yet recruiting
• Trial end date: 2021-10-18
• Target enrollment: 0
• Participant gender: Male

Summary

A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kunming Pharmaceuticals, Inc.
• Treatments: Denosumab

Criteria

Inclusion Criteria:

1. Aged ≥18 years or ≤65 years, male(including the boundary value).

2. The body weight is within the range of 50~70kg (including the boundary value) and the body mass index（BMI） is within the range of 19.0~26.0kg/m2 (including the boundary value).

3. Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements.

4. The volunteers are able to communicate well with the researchers, understand and comply with the requirements of the study, and are expected to participate in all follow-up visits (no long-term plans to leave the study site).

Exclusion Criteria:

1. Have participated in any drug or medical device trials or are participating in other clinical trials within 3 months prior to first administration.

2. Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.

3. The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed.

4. Occurred or suffering hypocalcemia.

5. Have taken any medicine (including Chinese herbal medicine) within 14 days before the first administration.