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

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: MV088 injection; Drug: Prolia® injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MV088; MV088 injection (60mg) by subcutaneous injection once on the first day	Drug: MV088 injection; MV088 injection (60mg) by subcutaneous injection once on the first day
ACTIVE_COMPARATOR: Prolia®; Prolia® injection (60mg) by subcutaneous injection once on the first day	Drug: Prolia® injection; Prolia® injection (60mg) by subcutaneous injection once on the first day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of MV088/Prolia in plasma: Cmax	To characterize the pharmacokinetic parameters#Cmax of MV088/Prolia after the first day administer	126 days
Pharmacokinetics of MV088/Prolia in plasma: AUC0-∞	To characterize the pharmacokinetic parameters#AUC0-∞ of MV088/Prolia after the first day administer	126 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Pharmacokinetics of MV088/Prolia in plasma: Tmax	To characterize the pharmacokinetic parameters#Tmax of MV088/Prolia after the first day administer	126 days
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
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
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
Pharmacokinetics of MV088/Prolia in plasma: λz	To characterize the pharmacokinetic parameters#λz of MV088/Prolia after the first day administer	126 days
Safety evaluation of MV088/Prolia	To characterize the Safety evaluation of MV088/Prolia after the first day administer	126 days
Immunogenicity evaluation of MV088/Prolia	To characterize the Immunogenicity evaluation of MV088/Prolia after the first day administer	126 days

Collaborators and Investigators

• Sponsor: Kunming Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Xin Li, ph.D, The Third Hospital of Changsha; Principal Investigator: Jianchang He, ph.D, Yunnan Provincial Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 22, 2021
• Primary Completion (ANTICIPATED): October 18, 2021
• Study Completion (ANTICIPATED): October 18, 2021

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 13, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Denosumab
• Other Study ID Numbers: KYJT-MV088-I01; CTR20202419 (OTHER: National Medical Products Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No