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

NCT03925051 | Completed Phase 1

• 1 other identifier: CMAB807-I-001
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (2)

• AUC0-t

  Area Under Curve(AUC)0-t

  0~126 day

• Cmax

  Maximum Concentration

  0~126 day

Secondary Outcomes (3)

• Incidence of Adverse Event

  0~126 day

• Antidrug Antibody

  0~126 day

• Serum type 1 C-telopeptide(CTX1)

  0~126 day

Study Arms (2)

CMAB807

EXPERIMENTAL

60mg by subcutaneous injection once on the first day.

Drug: CMAB807

Prolia®

ACTIVE COMPARATOR

60mg by subcutaneous injection once on the first day.

Drug: Prolia®

Interventions

Prolia® DRUG

mAb targeting RANKL. human monoclonal antibody targeting RANKL.

Also known as: Denosumab Injection

Prolia®

CMAB807 DRUG

human monoclonal antibody targeting RANKL.

Also known as: Denosumab Injection

CMAB807

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand and voluntary sign the informed consent form,and be able to complete the study according to the protocol;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Biomabs Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 35140619 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• xuening li, PhD

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: subjects, investigator, sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-masked, Parallel-group

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: July 1, 2019
• Primary Completion: March 21, 2020
• Study Completion: June 18, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)