Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    CMAB807

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03925051
Recruitment Status : Completed
First Posted : April 23, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Biomabs Pharmaceutical Co., Ltd.

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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Denosumab

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925051


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
Layout table for additonal information
Responsible Party: Shanghai Biomabs Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03925051    
Other Study ID Numbers: CMAB807-I-001
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs