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

NCT ID: NCT04673799

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2021-10-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized、double-blind、parallel-group、single-dosed、positive control
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MV088

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

Group Type EXPERIMENTAL

MV088 injection

Intervention Type DRUG

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

Prolia®

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

Group Type ACTIVE_COMPARATOR

Prolia® injection

Intervention Type DRUG

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

Interventions

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MV088 injection

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

Intervention Type DRUG

Prolia® injection

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kunming Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xin Li, ph.D

Role: PRINCIPAL_INVESTIGATOR

The Third Hospital of Changsha

Jianchang He, ph.D

Role: PRINCIPAL_INVESTIGATOR

Yunnan Provincial Hospital of Traditional Chinese Medicine

Central Contacts

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Duo Gao

Role: CONTACT

Phone: 008613032237118

Email: [email protected]

Other Identifiers

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CTR20202419

Identifier Type: OTHER

Identifier Source: secondary_id

KYJT-MV088-I01

Identifier Type: -

Identifier Source: org_study_id