Osteoporosis, PostmenopausalPhase 1MW031NCT04798313
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults
A Phase 1 study testing MW031 and Prolia® in people with Osteoporosis, Postmenopausal, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 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
- Osteoporosis, Postmenopausal
- What is being tested?
- MW031 and Prolia®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2020to 31 Dec 2020
- 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
- Age: 18-65 years old (including 18 and 65 years old), healthy male subjects.
- Body mass index (BMI) within the range 19-28kg/m2.
- History, physical examination, laboratory tests and test related items of inspection were normal or mildly abnormal clinically insignificant.
- Volunteered to participate in this clinical trial, capable of giving written informed consentan.
- The subject (including the subject's partner) takes effective contraceptive measures.
Who cannot join
- Nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the results of the study.
- Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
- Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
- Subject has viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies.
- Those who have used the following drugs within 1 month or 5 half-lives (whichever is longer) before participating in this study, including but not limited to: estrogen-containing contraceptives, bisphosphonates, fluoride, hormone replacement Treatment (ie tibolone, estrogen, estrogen-like compounds, such as raloxifene), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (>1000 IU/day), corticosteroids (inhaled or topical corticosteroids can be used 2 weeks before enrollment), anabolic hormone drugs, calcitriol, diuretics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW031 and Prolia® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.
Read the detailed description
This is a phase I, single center, randomized, double-blind and parallel group clinical trial.
The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers.
The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers.
At the same time, preliminary evaluate the pharmacodynamic similarity between MW031 and Prolia®.
Subjects would receive a single 60mg（1mL）of MW031 or Prolia® through subcutaneous injection.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- MW031, Prolia®
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MW031Drug
Subjects would receive a single 60mg (1 mL) of MW031 through subcutaneous injection, on the first day of treatment.
Prolia®Drug
Subjects would receive a single 60mg (1 mL) of Prolia® through subcutaneous injection, on the first day of treatment.
| Study group | Role | What they receive |
|---|---|---|
| MW031 | Experimental | MW031 injection (60mg) by subcutaneous injection once on the first day of treatment. Receives: Drug: MW031 |
| Prolia® | Active comparator | Prolia® injection (60mg) by subcutaneous injection once on the first day of treatment. Receives: Drug: Prolia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC0-t )
Measured: Day0-Day140
Maximum serum concentration (Cmax)
Measured: Day0-Day140
Secondary outcomes (2)
Adverse events(AE)
The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.
Measured: Day0-Day140
serum CTX1
CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.
Measured: Day0-Day140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start2 Jun 2020
- Primary completion7 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798313
- Sponsor's protocol ID
- MW031-2020-CP101
- Acronym
- MW031
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo Y, Guo T, Di Y, Xu W, Hu Z, Xiao Y, Yu H, Hou J. Pharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):705-715. doi: 10.1080/14712598.2023.2178298. Epub 2023 Mar 9.
PubMed 36892190
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind , Single-dose, and Parallel Group Study to Compare the Pharmacokinetic, Safety and Pharmacodynamic of MW031 and Prolia® in Healthy Adults
- ClinicalTrials.gov ID
- NCT04798313
- Acronym / sponsor ID
- MW031 / MW031-2020-CP101
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Mar 2021 (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 pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.
Detailed description
This is a phase I, single center, randomized, double-blind and parallel group clinical trial.
The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers.
The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW031 and Prolia® in healthy volunteers.
At the same time, preliminary evaluate the pharmacodynamic similarity between MW031 and Prolia®.
Subjects would receive a single 60mg（1mL）of MW031 or Prolia® through subcutaneous injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MW031 | Experimental | Drug: MW031MW031 injection (60mg) by subcutaneous injection once on the first day of treatment. |
| Prolia® | Active comparator | Drug: Prolia®Prolia® injection (60mg) by subcutaneous injection once on the first day of treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-65 years old (including 18 and 65 years old), healthy male subjects.
- Body mass index (BMI) within the range 19-28kg/m2.
- History, physical examination, laboratory tests and test related items of inspection were normal or mildly abnormal clinically insignificant.
- Volunteered to participate in this clinical trial, capable of giving written informed consentan.
- The subject (including the subject's partner) takes effective contraceptive measures.
Key exclusion criteria (5 listed)
- Nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system diseases, liver and kidney dysfunction, or any other diseases and physiological conditions that may affect the results of the study.
- Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously.
- Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
- Subject has viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies.
- Those who have used the following drugs within 1 month or 5 half-lives (whichever is longer) before participating in this study, including but not limited to: estrogen-containing contraceptives, bisphosphonates, fluoride, hormone replacement Treatment (ie tibolone, estrogen, estrogen-like compounds, such as raloxifene), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (>1000 IU/day), corticosteroids (inhaled or topical corticosteroids can be used 2 weeks before enrollment), anabolic hormone drugs, calcitriol, diuretics.
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 |
|---|---|---|
| MW031Subjects would receive a single 60mg (1 mL) of MW031 through subcutaneous injection, on the first day of treatment. | Drug | MW031 |
| Prolia®Subjects would receive a single 60mg (1 mL) of Prolia® through subcutaneous injection, on the first day of treatment. | Drug | Prolia® |
Primary outcome
Area under the plasma concentration-time curve (AUC0-t )
Time frame: Day0-Day140
Maximum serum concentration (Cmax)
Time frame: Day0-Day140
2 secondary outcomes
Adverse events(AE)
Time frame: Day0-Day140
serum CTX1
Time frame: Day0-Day140
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Derived from this study: PubMed 36892190Guo Y, Guo T, Di Y, Xu W, Hu Z, Xiao Y, Yu H, Hou J. Pharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):705-715. doi: 10.1080/14712598.2023.2178298. Epub 2023 Mar 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MW031 and Prolia® in people with Osteoporosis, Postmenopausal, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve (AUC0-t ) (time frame: Day0-Day140). 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?
On the ClinicalTrials.gov record for NCT04798313, which also lists 1 linked publication.
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 15 Mar 2021.