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

KPC Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Prolia® injection; Drug: MV088 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04673799

KYJT-MV088-I01

CTR20202419 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 144 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups

MV088

Experimental group

Description:

MV088 injection (60mg) by subcutaneous injection once on the first day

Treatment:

Drug: MV088 injection

Prolia®

Active Comparator group

Description:

Prolia® injection (60mg) by subcutaneous injection once on the first day

Treatment:

Drug: Prolia® injection