- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03925051
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
A Randomized, Double-masked, Parallel-group Study, to Compare Pharmacokinetics, Safety and Immunogenicity of CMAB807 Injection Versus Prolia® in Healthy Chinese Male Subjects.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Zhongshan Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CMAB807
60mg by subcutaneous injection once on the first day.
|
human monoclonal antibody targeting RANKL.
Other Names:
|
ACTIVE_COMPARATOR: Prolia®
60mg by subcutaneous injection once on the first day.
|
mAb targeting RANKL.
human monoclonal antibody targeting RANKL.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-t
Time Frame: 0~126 day
|
Area Under Curve(AUC)0-t
|
0~126 day
|
Cmax
Time Frame: 0~126 day
|
Maximum Concentration
|
0~126 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Event
Time Frame: 0~126 day
|
measured by common terminology criteria for adverse events grading
|
0~126 day
|
Antidrug Antibody
Time Frame: 0~126 day
|
Percentage of Subjects Positive for Antidrug Antibody
|
0~126 day
|
Serum type 1 C-telopeptide(CTX1)
Time Frame: 0~126 day
|
explore the pharmacodynamic profile by detect the serum concentration of CTX1
|
0~126 day
|
Collaborators and Investigators
Investigators
- Study Chair: xuening li, PhD, Fudan University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMAB807-I-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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