Condition or disease | Intervention/treatment | Phase |
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Postmenopausal Osteoporosis | Drug: Prolia® Drug: CMAB807 | Phase 1 |
This is a phase 1 single center, randomized, double-masked, parallel-group clinical trial. The primary objective is to assess the pharmacokinetics similarity of single and subcutaneous injection of CMAB807 injection or Prolia® in health volunteers. The secondary objectives are to assess the clinical safety and immnogenicity similarity of single and subcutaneous injection of CMAB807 or Prolia® in healty volunteers. Meanwhile, exploring the pharmacodynamic similarities of CMAB807 and Prolia®.
Subjects will receive a single 60mg of CMAB807 or Prolia® through subcutaneous injection.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 132 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized, Double-masked, Parallel-group |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | subjects, investigator, sponsor |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-masked, Parallel-group Study, to Compare Pharmacokinetics, Safety and Immunogenicity of CMAB807 Injection Versus Prolia® in Healthy Chinese Male Subjects. |
Actual Study Start Date : | July 1, 2019 |
Actual Primary Completion Date : | March 21, 2020 |
Actual Study Completion Date : | June 18, 2020 |
Arm | Intervention/treatment |
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Experimental: CMAB807
60mg by subcutaneous injection once on the first day.
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Drug: CMAB807
human monoclonal antibody targeting RANKL.
Other Name: Denosumab Injection
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Active Comparator: Prolia®
60mg by subcutaneous injection once on the first day.
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Drug: Prolia®
mAb targeting RANKL. human monoclonal antibody targeting RANKL.
Other Name: Denosumab Injection
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
China, Shanghai | |
Zhongshan Hospital | |
Shanghai, Shanghai, China, 200032 |
Study Chair: | xuening li, PhD | Fudan University |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 18, 2019 | ||||||
First Posted Date ICMJE | April 23, 2019 | ||||||
Last Update Posted Date | October 14, 2020 | ||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||
Actual Primary Completion Date | March 21, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers | ||||||
Official Title ICMJE | A Randomized, Double-masked, Parallel-group Study, to Compare Pharmacokinetics, Safety and Immunogenicity of CMAB807 Injection Versus Prolia® in Healthy Chinese Male Subjects. | ||||||
Brief Summary | CMAB807 is a human monoclonal antibody targeting the key bone resorption mediator RANKL. The drug is administered via subcutaneous injection once six months and is approved for various indications, including the treatment of postmenopausal women with osteoporosis at increased/high risk of fracture. This phase 1 clincical study investigates the pharmacokinetics, safety and immnogenicity of CMAB807,compared to prolia®, in healthy Chinese male subjects. | ||||||
Detailed Description |
This is a phase 1 single center, randomized, double-masked, parallel-group clinical trial. The primary objective is to assess the pharmacokinetics similarity of single and subcutaneous injection of CMAB807 injection or Prolia® in health volunteers. The secondary objectives are to assess the clinical safety and immnogenicity similarity of single and subcutaneous injection of CMAB807 or Prolia® in healty volunteers. Meanwhile, exploring the pharmacodynamic similarities of CMAB807 and Prolia®. Subjects will receive a single 60mg of CMAB807 or Prolia® through subcutaneous injection. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, Double-masked, Parallel-group Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: subjects, investigator, sponsor Primary Purpose: Treatment
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Condition ICMJE | Postmenopausal Osteoporosis | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
132 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | June 18, 2020 | ||||||
Actual Primary Completion Date | March 21, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | China | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03925051 | ||||||
Other Study ID Numbers ICMJE | CMAB807-I-001 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Shanghai Biomabs Pharmaceutical Co., Ltd. | ||||||
Study Sponsor ICMJE | Shanghai Biomabs Pharmaceutical Co., Ltd. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Shanghai Biomabs Pharmaceutical Co., Ltd. | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |