4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers

Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers

Study Description
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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Prolia® Drug: CMAB807 Phase 1

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.

Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: CMAB807
60mg by subcutaneous injection once on the first day.
Drug: CMAB807
human monoclonal antibody targeting RANKL.
Other Name: Denosumab Injection

Active Comparator: Prolia®
60mg by subcutaneous injection once on the first day.
Drug: Prolia®
mAb targeting RANKL. human monoclonal antibody targeting RANKL.
Other Name: Denosumab Injection

Outcome Measures
Primary Outcome Measures :
  1. AUC0-t [ Time Frame: 0~126 day ]
    Area Under Curve(AUC)0-t

  2. Cmax [ Time Frame: 0~126 day ]
    Maximum Concentration


Secondary Outcome Measures :
  1. Incidence of Adverse Event [ Time Frame: 0~126 day ]
    measured by common terminology criteria for adverse events grading

  2. Antidrug Antibody [ Time Frame: 0~126 day ]
    Percentage of Subjects Positive for Antidrug Antibody

  3. Serum type 1 C-telopeptide(CTX1) [ Time Frame: 0~126 day ]
    explore the pharmacodynamic profile by detect the serum concentration of CTX1


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fully understand and voluntary sign the informed consent form,and be able to complete the study according to the protocol;
  • 18 years ≤ age ≤65 years;
  • Physical examination, vital signs, clinical laboratory examination and various examinations are normal or abnormal without clinical significance;
  • Agree to take effective contraceptive measures throughout the study period (including not limited to: physical contraception, hormonal drugs of pregnancy, surgery, abstinence, etc.,) until at least 10 months after the last study is administered;
  • Body weight ≥50 kg, 19kg/m2≤BMI≤26kg/m2;
  • Serum calcium level between 2.15~2.55mmol/L(including the boundary value);
  • Normal or clinically acceptable electrocardiogram (12-lead ECG), QTcB<450msec.

Exclusion Criteria:

  • Drink 14 units of alcohol per week within 3 months prior to administration, or take any alcohol substance within 48 hours before subcutaneous injection;
  • Substance abuse within 5 years before subcutaneous injection;
  • Smoke more than 5 cigarettes per day or the same amount of tobacco within 3 months before subcutaneous injection;
  • Allergic constitution;
  • Drink excessive amounts of tea, coffee or caffeinated beverages within 30 days before subcutaneous injection;
  • Use any prescription, over-the-counter, vitamin or herbal medicine within 30 days before subcutaneous injection;
  • Bone surgery was performed within 30 days before administration;
  • History of osteomyelitis or osteonecrosis of the jaw;
  • Inflammation or abnormalities in or around the site of administration;
  • Needle or blood sickness;
  • Dental disease or jaw disease requiring oral surgery, dental surgery; or plan to have dental surgery during the study;
  • Received the study drug(including Xgeva and Prolia), or participated in a clinical trial within 3 months prior to administration;
  • Received living viraL vaccine within 3 months prior to administration;
  • Blood donation or blood loss >400ml within 3 months prior to administration;
  • Hepatitis B surface antigen was positive, and/or hepatitis C antibody was positive;
  • The HIV antibody test was not negative;
  • Syphilitic test was positive;
  • Drug was detected in the urine;
  • Hyperparathyroidism, hypothyroidism, rheumatoid arthritis, Ankylosing Spondylitis, osteomalacia, Paget's disease, or fracture within 6 months;
  • History of severe lumbar disc herniation;
  • Insanity or legal problem are exist;
  • Plan to engage in strenuous physical labor or exercise during the study;
  • Other conditions that made it difficult to participate the study.
Contacts and Locations

Locations
Layout table for location information
China, Shanghai
Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Biomabs Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
Study Chair: xuening li, PhD Fudan University
Tracking Information
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
 (submitted: April 20, 2019)
  • AUC0-t [ Time Frame: 0~126 day ]
    Area Under Curve(AUC)0-t
  • Cmax [ Time Frame: 0~126 day ]
    Maximum Concentration
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2019)
  • Incidence of Adverse Event [ Time Frame: 0~126 day ]
    measured by common terminology criteria for adverse events grading
  • Antidrug Antibody [ Time Frame: 0~126 day ]
    Percentage of Subjects Positive for Antidrug Antibody
  • Serum type 1 C-telopeptide(CTX1) [ Time Frame: 0~126 day ]
    explore the pharmacodynamic profile by detect the serum concentration of CTX1
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.

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
Condition  ICMJE Postmenopausal Osteoporosis
Intervention  ICMJE
  • Drug: Prolia®
    mAb targeting RANKL. human monoclonal antibody targeting RANKL.
    Other Name: Denosumab Injection
  • Drug: CMAB807
    human monoclonal antibody targeting RANKL.
    Other Name: Denosumab Injection
Study Arms  ICMJE
  • Experimental: CMAB807
    60mg by subcutaneous injection once on the first day.
    Intervention: Drug: CMAB807
  • Active Comparator: Prolia®
    60mg by subcutaneous injection once on the first day.
    Intervention: Drug: Prolia®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2019)
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:

  • Fully understand and voluntary sign the informed consent form,and be able to complete the study according to the protocol;
  • 18 years ≤ age ≤65 years;
  • Physical examination, vital signs, clinical laboratory examination and various examinations are normal or abnormal without clinical significance;
  • Agree to take effective contraceptive measures throughout the study period (including not limited to: physical contraception, hormonal drugs of pregnancy, surgery, abstinence, etc.,) until at least 10 months after the last study is administered;
  • Body weight ≥50 kg, 19kg/m2≤BMI≤26kg/m2;
  • Serum calcium level between 2.15~2.55mmol/L(including the boundary value);
  • Normal or clinically acceptable electrocardiogram (12-lead ECG), QTcB<450msec.

Exclusion Criteria:

  • Drink 14 units of alcohol per week within 3 months prior to administration, or take any alcohol substance within 48 hours before subcutaneous injection;
  • Substance abuse within 5 years before subcutaneous injection;
  • Smoke more than 5 cigarettes per day or the same amount of tobacco within 3 months before subcutaneous injection;
  • Allergic constitution;
  • Drink excessive amounts of tea, coffee or caffeinated beverages within 30 days before subcutaneous injection;
  • Use any prescription, over-the-counter, vitamin or herbal medicine within 30 days before subcutaneous injection;
  • Bone surgery was performed within 30 days before administration;
  • History of osteomyelitis or osteonecrosis of the jaw;
  • Inflammation or abnormalities in or around the site of administration;
  • Needle or blood sickness;
  • Dental disease or jaw disease requiring oral surgery, dental surgery; or plan to have dental surgery during the study;
  • Received the study drug(including Xgeva and Prolia), or participated in a clinical trial within 3 months prior to administration;
  • Received living viraL vaccine within 3 months prior to administration;
  • Blood donation or blood loss >400ml within 3 months prior to administration;
  • Hepatitis B surface antigen was positive, and/or hepatitis C antibody was positive;
  • The HIV antibody test was not negative;
  • Syphilitic test was positive;
  • Drug was detected in the urine;
  • Hyperparathyroidism, hypothyroidism, rheumatoid arthritis, Ankylosing Spondylitis, osteomalacia, Paget's disease, or fracture within 6 months;
  • History of severe lumbar disc herniation;
  • Insanity or legal problem are exist;
  • Plan to engage in strenuous physical labor or exercise during the study;
  • Other conditions that made it difficult to participate the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanghai Biomabs Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Shanghai Biomabs Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: xuening li, PhD Fudan University
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