A Randomized, Double-masked, Parallel-group Study, to Compare Pharmacokinetics, Safety and Immunogenicity of CMAB807 Injection Versus Prolia® in Healthy Chinese Male Subjects.

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

Sponsors

Lead sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd.

Source 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.

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.

Overall Status Active, not recruiting
Start Date July 1, 2019
Completion Date June 21, 2020
Primary Completion Date March 21, 2020
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
AUC0-t 0~126 day
Cmax 0~126 day
Secondary Outcome
Measure Time Frame
Incidence of Adverse Event 0~126 day
Antidrug Antibody 0~126 day
Serum type 1 C-telopeptide(CTX1) 0~126 day
Enrollment 132
Condition
Intervention

Intervention type: Drug

Intervention name: Prolia®

Description: mAb targeting RANKL. human monoclonal antibody targeting RANKL.

Arm group label: Prolia®

Other name: Denosumab Injection

Intervention type: Drug

Intervention name: CMAB807

Description: human monoclonal antibody targeting RANKL.

Arm group label: CMAB807

Eligibility

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.

Gender: Male

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
xuening li, PhD Study Chair Fudan University
Location
facility Zhongshan Hospital
Location Countries

China

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CMAB807

Arm group type: Experimental

Description: 60mg by subcutaneous injection once on the first day.

Arm group label: Prolia®

Arm group type: Active Comparator

Description: 60mg by subcutaneous injection once on the first day.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized, Double-masked, Parallel-group

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: subjects, investigator, sponsor

Source: ClinicalTrials.gov