Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers

NCT05808673 | Withdrawn Phase 1

• 1 other identifier: CMAB807X-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blinded, controlled Phase I three-arms study of CMAB807X administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807X Pre- and Post-change in Manufacturing Site, and Post-change CMAB807X versus Xgeva® #Denosumab# in healthy male subjects after a single dose

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time

  Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single injection of Denosumab

  up to 3336 hours

• Maximum Concentration of Denosumab

  Maximum Concentration of Denosumab After the Single Injection of denosumab

  up to 3336 hours

Secondary Outcomes (8)

• Time to Maximum Concentration of Denosumab

  up to 3336 hours

• Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3336 Hours

  up to 3336 hours

• Half time

  up to 3336 hours

• Clearance Rate

  up to 3336 hours

• Apparent Volume of Distribution

  up to 3336 hours

Other Outcomes (1)

• Percentage and Severity of Participants with Adverse Events

  up to 3336 hours

Study Arms (3)

Post-change CMAB807X

EXPERIMENTAL

120 mg Subcutaneous injection around belly button

Biological: Post-change CMAB807X

Pre-change CMAB807X

OTHER

120 mg Subcutaneous injection around belly button

Biological: Pre-change CMAB807X

Xgeva®

ACTIVE COMPARATOR

120 mg Subcutaneous injection around belly button

Biological: Xgeva®

Interventions

Post-change CMAB807X BIOLOGICAL

for subcutaneous injection only

Post-change CMAB807X

Pre-change CMAB807X BIOLOGICAL

for subcutaneous injection only

Pre-change CMAB807X

Xgeva® BIOLOGICAL

for subcutaneous injection only

Xgeva®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers, age ranged 18 to 45 years (both inclusive) when sign the informed consent form.
• Subjects with body weight of ≥58 kg and ≤ 68 kg and BMI ≥18 and ≤ 28 kg/m2.
• Subjects were willing to take effective contraceptive measures throughout the study period (including: physical contraception, surgery, abstinence, etc.,) until at least 6 months after administration.
• Subjects have the ability to understand the full characteristics and objectives of the study, including the possible risks and side effects of the study; moreover, subjects can communicate well with researchers and complete the research according to the regulations.
• Subjects must be informed consent of the study and voluntarily sign ICF (name and time) prior to the study.

You may not qualify if:

• After medical examination (vital signs, physical examination, electrocardiogram, chest X-radiography, cervical and abdominal B-ultrasound, and various laboratory examinations including blood routine, urine routine, blood biochemistry, etc.), any examination item was judged abnormal by the investigator and had clinical significance.
• Serum calcium level were out of the normal range.
• QTcF \> 450 ms (12-lead ECG).
• Inflammation or abnormalities in or around the site of administration.
• Those who have a history of serious diseases including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, urinary system, digestive system, respiratory system, metabolic and skeletal systems, or currently have any of the above diseases or active infected diseases, or any other disease or medical condition that may interfere with the results of the trial, such as hereditary bleeding tendency, coagulation disorders or history of blood clots or bleeding.
• Previous diagnosis of bone disorders that the investigator has determined to be clinically significant, or any disease that affects bone metabolism, including but not limited to: malignant tumors (including myeloma), hypothyroidism/hyperthyroidism, hypoparathyroidism/hyperthyroidism, acromegaly, Cushing's syndrome, hypopituitarism, severe chronic obstructive pulmonary disease, rheumatoid arthritis, osteomalacia, etc.
• Subjects with past or current osteomyelitis or osteonecrosis of the jaw (ONJ), or risk factors for ONJ, such as dental disease or jaw disease requiring oral surgery, dental surgery; or plan to have dental surgery during the study.
• Fracture occurred within 6 months prior to signing ICF.
• Surgery within 6 months prior to signing ICF, or plan to have surgery during the study period.
• Allergic to two or more drugs or foods, or to any component of the investigational agent.
• Use of any prescription drug, over-the-counter drug, vitamin or herbal medicine within 30 days prior to signing ICF, or prior use of drugs within 5 half-lives, whichever is longer.
• Use of any medications that have the potential to affect bone metabolism prior to administration (e.g., bisphosphonate or fluoride, estrogen, selective estrogen receptor modulators, calcitonin, parathyroid hormone, high-dose vitamin D (\> 1000 IU/ day), anabolic steroids, systemic glucocorticoids, or percalcitriol within 6 months)
• Use of anti-RANKL mab within 12 months, or any biological agent within 3 months prior to signing ICF.
• Those who have received vaccine within the 4 weeks prior to signing ICF, or who plan to receive live vaccine during the study period.
• History of drug abuse, or positive urine drug screening.

Sponsors & Collaborators

• Taizhou Mabtech Pharmaceutical Co.,Ltd: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hu Wei, Doctor

  The Second Hospital of Anhui University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Biological: Pre- and Post-change CMAB807X, Xgeva®

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 11, 2023
• Study Start: February 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)