HealthyPhase 1NCT04673799
Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
A Phase 1 study testing MV088 injection and Prolia® injection in people with Healthy, run by Kunming Pharmaceuticals, Inc..
Trial summary
A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MV088 injection and Prolia® injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2021to 18 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years or ≤65 years, male(including the boundary value).
- 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).
- 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.
- 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).
Who cannot join
- Have participated in any drug or medical device trials or are participating in other clinical trials within 3 months prior to first administration.
- Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
- 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.
- Occurred or suffering hypocalcemia.
- Have taken any medicine (including Chinese herbal medicine) within 14 days before the first administration.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- MV088 injection, Prolia® injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MV088 injectionDrug
MV088 injection (60mg) by subcutaneous injection once on the first day
Prolia® injectionDrug
Prolia® injection (60mg) by subcutaneous injection once on the first day
| Study group | Role | What they receive |
|---|---|---|
| MV088 | Experimental | MV088 injection (60mg) by subcutaneous injection once on the first day Receives: Drug: MV088 injection |
| Prolia® | Active comparator | Prolia® injection (60mg) by subcutaneous injection once on the first day Receives: Drug: Prolia® injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of MV088/Prolia in plasma: Cmax
To characterize the pharmacokinetic parameters#Cmax of MV088/Prolia after the first day administer
Measured: 126 days
Pharmacokinetics of MV088/Prolia in plasma: AUC0-∞
To characterize the pharmacokinetic parameters#AUC0-∞ of MV088/Prolia after the first day administer
Measured: 126 days
Secondary outcomes (8)
Pharmacokinetics of MV088/Prolia in plasma: AUC0-t
To characterize the pharmacokinetic parameters#AUC0-t of MV088/Prolia after the first day administer
Measured: 126 days
Pharmacokinetics of MV088/Prolia in plasma: Tmax
To characterize the pharmacokinetic parameters#Tmax of MV088/Prolia after the first day administer
Measured: 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
Measured: 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
Measured: 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
Measured: 126 days
Pharmacokinetics of MV088/Prolia in plasma: λz
To characterize the pharmacokinetic parameters#λz of MV088/Prolia after the first day administer
Measured: 126 days
Safety evaluation of MV088/Prolia
To characterize the Safety evaluation of MV088/Prolia after the first day administer
Measured: 126 days
Immunogenicity evaluation of MV088/Prolia
To characterize the Immunogenicity evaluation of MV088/Prolia after the first day administer
Measured: 126 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start22 Feb 2021 (estimated)
- Primary completion18 Oct 2021 (estimated)
- Study completion18 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized、double-blind、parallel-group、single-dosed、positive control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xin Li, ph.D, Principal investigator, Changsha Third HospitalJianchang He, ph.D, Principal investigator, Yunnan Provinical Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673799
- Sponsor's protocol ID
- KYJT-MV088-I01
- Other IDs
- CTR20202419
- Status last verified
- Dec 2020
- First submitted
- 13 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind and Parallel Group Study to Compare the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.
- ClinicalTrials.gov ID
- NCT04673799
- Acronym / sponsor ID
- KYJT-MV088-I01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Kunming Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (estimated)
- Primary completion
- 18 Oct 2021 (estimated)
- Study completion
- 18 Oct 2021 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized、double-blind、parallel-group、single-dosed、positive control
| Arm | Type | Receives |
|---|---|---|
| MV088 | Experimental | Drug: MV088 injectionMV088 injection (60mg) by subcutaneous injection once on the first day |
| Prolia® | Active comparator | Drug: Prolia® injectionProlia® injection (60mg) by subcutaneous injection once on the first day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18 years or ≤65 years, male(including the boundary value).
- 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).
- 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.
- 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).
Key exclusion criteria (5 listed)
- Have participated in any drug or medical device trials or are participating in other clinical trials within 3 months prior to first administration.
- Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
- 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.
- Occurred or suffering hypocalcemia.
- Have taken any medicine (including Chinese herbal medicine) within 14 days before the first administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MV088 injectionMV088 injection (60mg) by subcutaneous injection once on the first day | Drug | MV088 |
| Prolia® injectionProlia® injection (60mg) by subcutaneous injection once on the first day | Drug | Prolia® |
Primary outcome
Pharmacokinetics of MV088/Prolia in plasma: Cmax
Time frame: 126 days
To characterize the pharmacokinetic parameters#Cmax of MV088/Prolia after the first day administer
Pharmacokinetics of MV088/Prolia in plasma: AUC0-∞
Time frame: 126 days
To characterize the pharmacokinetic parameters#AUC0-∞ of MV088/Prolia after the first day administer
8 secondary outcomes
Pharmacokinetics of MV088/Prolia in plasma: AUC0-t
Time frame: 126 days
Pharmacokinetics of MV088/Prolia in plasma: Tmax
Time frame: 126 days
Pharmacokinetics of MV088/Prolia in plasma: t1/2
Time frame: 126 days
Pharmacokinetics of MV088/Prolia in plasma: CLz/F
Time frame: 126 days
Pharmacokinetics of MV088/Prolia in plasma: Vz/F
Time frame: 126 days
Pharmacokinetics of MV088/Prolia in plasma: λz
Time frame: 126 days
Safety evaluation of MV088/Prolia
Time frame: 126 days
Immunogenicity evaluation of MV088/Prolia
Time frame: 126 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Li, ph.D principal investigator
Changsha Third Hospital
Jianchang He, ph.D principal investigator
Yunnan Provinical Hospital of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MV088 injection and Prolia® injection in people with Healthy, run by Kunming Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duo Gao (008613032237118, duo.gao@kpc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of MV088/Prolia in plasma: Cmax (time frame: 126 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.