Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
NCT04673799 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2020-12-17
Summary
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
Conditions
- Healthy
Interventions
- DRUG
-
MV088 injection
MV088 injection (60mg) by subcutaneous injection once on the first day
- DRUG
-
Prolia® injection
Prolia® injection (60mg) by subcutaneous injection once on the first day
Sponsors & Collaborators
-
Kunming Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Xin Li, ph.D · The Third Hospital of Changsha
-
Jianchang He, ph.D · Yunnan Provincial Hospital of Traditional Chinese Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-02-22
- Primary Completion
- 2021-10-18
- Completion
- 2021-10-18
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