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

October 9, 2020 updated by: Shanghai Biomabs Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

132

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Denosumab Injection
ACTIVE_COMPARATOR: Prolia®
60mg by subcutaneous injection once on the first day.
mAb targeting RANKL. human monoclonal antibody targeting RANKL.
Other Names:
  • Denosumab Injection

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: xuening li, PhD, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

March 21, 2020

Study Completion (ACTUAL)

June 18, 2020

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

April 20, 2019

First Posted (ACTUAL)

April 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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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