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

April 7, 2024 updated by: Taizhou Mabtech Pharmaceutical Co.,Ltd

A Randomized, Double-blind, Parallel Controlled, Phase I Three-arm Study, Comparing the PK, PD, Safety, and Immunogenicity of Pre- and Post-change CMAB807X, Post-change CMAB807X and Xgeva® in Healthy Chinese Male Subjects

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, parallel-controlled, single-dose phase I three-arms clinical study in healthy Chinese male subjects. A total of 252 subjects were planned to be enrolled and randomly assigned to the test group or the bridging control group or bioequivalence control group in a 1:1:1 ratio. Subjects in three groups received a single abdominal subcutaneous injection of pre- or post-change CMAB807X or Xgeva® #Denosumab# 120 mg, respectively. Subjects in three groups were observed for 140 days after administration to evaluate similarities in pharmacokinetics, pharmacodynamics, safety, and immunogenicity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Zhang Jing
  • Phone Number: 0551-63806061

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • The Second Hospital of Anhui Medical University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy male volunteers, age ranged 18 to 45 years (both inclusive) when sign the informed consent form.
  2. Subjects with body weight of ≥58 kg and ≤ 68 kg and BMI ≥18 and ≤ 28 kg/m2.
  3. 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.
  4. 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.
  5. Subjects must be informed consent of the study and voluntarily sign ICF (name and time) prior to the study.

Exclusion Criteria:

  1. 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.
  2. Serum calcium level were out of the normal range.
  3. QTcF > 450 ms (12-lead ECG).
  4. Inflammation or abnormalities in or around the site of administration.
  5. 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.
  6. 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.
  7. 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.
  8. Fracture occurred within 6 months prior to signing ICF.
  9. Surgery within 6 months prior to signing ICF, or plan to have surgery during the study period.
  10. Allergic to two or more drugs or foods, or to any component of the investigational agent.
  11. 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.
  12. 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)
  13. Use of anti-RANKL mab within 12 months, or any biological agent within 3 months prior to signing ICF.
  14. Those who have received vaccine within the 4 weeks prior to signing ICF, or who plan to receive live vaccine during the study period.
  15. History of drug abuse, or positive urine drug screening.
  16. Those who had donated or lost blood at least 200 mL in the 3 months prior to signing ICF, or planned to donate blood during the study.
  17. Those who can not tolerate venipunction, has a history of dizziness of needle and blood.
  18. Those who have been enrolled in other drug or device clinical studies within 3 months prior to signing ICF.
  19. Those who smoked more than 5 cigarettes per day in the 6 months prior to signing ICF and did not cooperate with smoking bans during the study period.
  20. Those who consumed more than 14 units of alcohol per week (1 unit = 17.7mL ethanol, i.e., 1 unit = 357mL 5% beer or 43mL 40% liquor or 147mL 12% wine) in the 3 months prior to signing ICF, or not willing to ban alcohol during the study period.
  21. Those who excessively daily consumed tea, coffee or caffeinated beverages (more than 8 cups, 1 cup =250mL) in the 3 months prior to signing ICF.
  22. Those who have special dietary requirements, or can not accept uniform diet
  23. Other conditions considered inappropriate to be included in this 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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Post-change CMAB807X
120 mg Subcutaneous injection around belly button
Biological: Post-change CMAB807X
for subcutaneous injection only
Other: Pre-change CMAB807X
120 mg Subcutaneous injection around belly button
Biological: Pre-change CMAB807X
for subcutaneous injection only
Active Comparator: Xgeva®
120 mg Subcutaneous injection around belly button
Biological: Xgeva®
for subcutaneous injection only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time
Time Frame: up to 3336 hours
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
Time Frame: up to 3336 hours
Maximum Concentration of Denosumab After the Single Injection of denosumab
up to 3336 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Maximum Concentration of Denosumab
Time Frame: up to 3336 hours
Time to Maximum Concentration of Denosumab after the Single Injection of
up to 3336 hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3336 Hours
Time Frame: up to 3336 hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3336 Hours After the Single Injection of Denosumab
up to 3336 hours
Half time
Time Frame: up to 3336 hours
Half-time after the Single Injection of Denosumab
up to 3336 hours
Clearance Rate
Time Frame: up to 3336 hours
Clearance Rate after the Single Injection of Denosumab
up to 3336 hours
Apparent Volume of Distribution
Time Frame: up to 3336 hours
Apparent Volume of Distribution after the Single Injection of Denosumab
up to 3336 hours
Serum type 1 C-telopeptide (CTX1)
Time Frame: up to 3336 hours
CTX1 level in the serum samples from subjects
up to 3336 hours
anti-drug antibodies(ADA)
Time Frame: up to 3336 hours
ADA Positive Rate after the Single Injection of Denosumab
up to 3336 hours
Neutralization antibodies(Nab)
Time Frame: up to 3336 hours
Neutralizing Antibody Positive Rate after the Single Injection of Denosumab
up to 3336 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage and Severity of Participants with Adverse Events
Time Frame: up to 3336 hours
Total Frequency and Severity of Adverse Events/Serious Adverse Events Within the Whole Time of the Study
up to 3336 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taizhou Mabtech Pharmaceutical Co.,Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hu Wei, Doctor, The Second Hospital of Anhui University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMAB807X-001

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

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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