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

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Prolia®
CMAB807
Sponsored by
Shanghai Biomabs Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CMAB807

Prolia®

Arm Description

60mg by subcutaneous injection once on the first day.

60mg by subcutaneous injection once on the first day.

Outcomes

Primary Outcome Measures

AUC0-t
Area Under Curve(AUC)0-t
Cmax
Maximum Concentration

Secondary Outcome Measures

Incidence of Adverse Event
measured by common terminology criteria for adverse events grading
Antidrug Antibody
Percentage of Subjects Positive for Antidrug Antibody
Serum type 1 C-telopeptide(CTX1)
explore the pharmacodynamic profile by detect the serum concentration of CTX1

Full Information

First Posted
April 18, 2019
Last Updated
October 9, 2020
Sponsor
Shanghai Biomabs Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03925051
Brief Title
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
March 21, 2020 (Actual)
Study Completion Date
June 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Biomabs Pharmaceutical Co., Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-masked, Parallel-group
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
subjects, investigator, sponsor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CMAB807
Arm Type
Experimental
Arm Description
60mg by subcutaneous injection once on the first day.
Arm Title
Prolia®
Arm Type
Active Comparator
Arm Description
60mg by subcutaneous injection once on the first day.
Intervention Type
Drug
Intervention Name(s)
Prolia®
Other Intervention Name(s)
Denosumab Injection
Intervention Description
mAb targeting RANKL. human monoclonal antibody targeting RANKL.
Intervention Type
Drug
Intervention Name(s)
CMAB807
Other Intervention Name(s)
Denosumab Injection
Intervention Description
human monoclonal antibody targeting RANKL.
Primary Outcome Measure Information:
Title
AUC0-t
Description
Area Under Curve(AUC)0-t
Time Frame
0~126 day
Title
Cmax
Description
Maximum Concentration
Time Frame
0~126 day
Secondary Outcome Measure Information:
Title
Incidence of Adverse Event
Description
measured by common terminology criteria for adverse events grading
Time Frame
0~126 day
Title
Antidrug Antibody
Description
Percentage of Subjects Positive for Antidrug Antibody
Time Frame
0~126 day
Title
Serum type 1 C-telopeptide(CTX1)
Description
explore the pharmacodynamic profile by detect the serum concentration of CTX1
Time Frame
0~126 day

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xuening li, PhD
Organizational Affiliation
Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35140619
Citation
Chen H, Chen W, Yuan F, Guo Q, Zhang X, Wang C, Li X. Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of CMAB807, a New Denosumab Biosimilar, in Healthy Chinese Subjects. Front Pharmacol. 2022 Jan 24;13:821944. doi: 10.3389/fphar.2022.821944. eCollection 2022.
Results Reference
derived

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

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