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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04673799
• Other study ID #: KYJT-MV088-I01
• Secondary ID: CTR20202419
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: February 22, 2021
• Est. completion date: October 18, 2021

Study information

• Verified date: December 2020
• Source: Kunming Pharmaceuticals, Inc.
• Contact: Duo Gao
• Phone: 008613032237118
• Email: duo.gao[@]kpc.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: October 18, 2021
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MV088 injection
MV088 injection (60mg) by subcutaneous injection once on the first day
• Prolia® injection
Prolia® injection (60mg) by subcutaneous injection once on the first day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kunming Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of MV088/Prolia in plasma: Cmax	To characterize the pharmacokinetic parameters#Cmax of MV088/Prolia after the first day administer	126 days
Primary	Pharmacokinetics of MV088/Prolia in plasma: AUC0-8	To characterize the pharmacokinetic parameters#AUC0-8 of MV088/Prolia after the first day administer	126 days
Secondary	Pharmacokinetics of MV088/Prolia in plasma: AUC0-t	To characterize the pharmacokinetic parameters#AUC0-t of MV088/Prolia after the first day administer	126 days
Secondary	Pharmacokinetics of MV088/Prolia in plasma: Tmax	To characterize the pharmacokinetic parameters#Tmax of MV088/Prolia after the first day administer	126 days
Secondary	Pharmacokinetics of MV088/Prolia in plasma: t1/2	To characterize the pharmacokinetic parameters#t1/2 of MV088/Prolia after the first day administer	126 days
Secondary	Pharmacokinetics of MV088/Prolia in plasma: CLz/F	To characterize the pharmacokinetic parameters#CLz/F of MV088/Prolia after the first day administer	126 days
Secondary	Pharmacokinetics of MV088/Prolia in plasma: Vz/F	To characterize the pharmacokinetic parameters#Vz/F of MV088/Prolia after the first day administer	126 days
Secondary	Pharmacokinetics of MV088/Prolia in plasma: ?z	To characterize the pharmacokinetic parameters#?z of MV088/Prolia after the first day administer	126 days
Secondary	Safety evaluation of MV088/Prolia	To characterize the Safety evaluation of MV088/Prolia after the first day administer	126 days
Secondary	Immunogenicity evaluation of MV088/Prolia	To characterize the Immunogenicity evaluation of MV088/Prolia after the first day administer	126 days