Clinical trial NCT04673799: Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
Official title: A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Kunming Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 144
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized、double-blind、parallel-group、single-dosed、positive control
Primary purpose: TREATMENT

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

Detailed description: This is a phase I, double center, randomized, double-blind, single dose and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of MV088 and Prolia® in healthy volunteers. The secondary objectives is to assess the similarity of clinical safety and immunogenicity of MV088 and Prolia® in healthy volunteers.

Eligibility 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.

Primary outcomes:
measure: Pharmacokinetics of MV088/Prolia in plasma: Cmax
timeFrame: 126 days
measure: Pharmacokinetics of MV088/Prolia in plasma: AUC0-∞
timeFrame: 126 days
Secondary outcomes:
measure: Pharmacokinetics of MV088/Prolia in plasma: AUC0-t
timeFrame: 126 days
measure: Pharmacokinetics of MV088/Prolia in plasma: Tmax
timeFrame: 126 days
measure: Pharmacokinetics of MV088/Prolia in plasma: t1/2
timeFrame: 126 days
measure: Pharmacokinetics of MV088/Prolia in plasma: CLz/F
timeFrame: 126 days
measure: Pharmacokinetics of MV088/Prolia in plasma: Vz/F
timeFrame: 126 days
measure: Pharmacokinetics of MV088/Prolia in plasma: λz
timeFrame: 126 days
measure: Safety evaluation of MV088/Prolia
timeFrame: 126 days
measure: Immunogenicity evaluation of MV088/Prolia
timeFrame: 126 days
Other outcomes:
Locations:
Study officials:
affiliation: The Third Hospital of Changsha
name: Xin Li, ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Yunnan Provincial Hospital of Traditional Chinese Medicine
name: Jianchang He, ph.D
role: PRINCIPAL_INVESTIGATOR
References: