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Healthy VolunteersPhase 1NCT05808673

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

A Phase 1 study testing Post-change CMAB807X, Pre-change CMAB807X and Xgeva® in people with Healthy Volunteers, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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®… Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Post-change CMAB807X, Pre-change CMAB807X and Xgeva®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
Feb 2023to Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • Those who can not tolerate venipunction, has a history of dizziness of needle and blood.
  • Those who have been enrolled in other drug or device clinical studies within 3 months prior to signing ICF.
  • 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.
  • 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.
  • 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.
  • Those who have special dietary requirements, or can not accept uniform diet
  • Other conditions considered inappropriate to be included in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

Other trials in China

About this study

Official title: 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

Read the 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.

Being tested
Post-change CMAB807X, Pre-change CMAB807X, Xgeva®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Post-change CMAB807XBiological

    for subcutaneous injection only

  • Pre-change CMAB807XBiological

    for subcutaneous injection only

  • Xgeva®Biological

    for subcutaneous injection only

Study groups in NCT05808673
Study groupRoleWhat they receive
Post-change CMAB807XExperimental120 mg Subcutaneous injection around belly button
Receives: Biological: Post-change CMAB807X
Pre-change CMAB807XOther120 mg Subcutaneous injection around belly button
Receives: Biological: Pre-change CMAB807X
Xgeva®Active comparator120 mg Subcutaneous injection around belly button
Receives: Biological: Xgeva®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 3336 hours

  2. Maximum Concentration of Denosumab

    Maximum Concentration of Denosumab After the Single Injection of denosumab

    Measured: up to 3336 hours

Secondary outcomes (8)

  1. Time to Maximum Concentration of Denosumab

    Time to Maximum Concentration of Denosumab after the Single Injection of

    Measured: up to 3336 hours

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

    Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3336 Hours After the Single Injection of Denosumab

    Measured: up to 3336 hours

  3. Half time

    Half-time after the Single Injection of Denosumab

    Measured: up to 3336 hours

  4. Clearance Rate

    Clearance Rate after the Single Injection of Denosumab

    Measured: up to 3336 hours

  5. Apparent Volume of Distribution

    Apparent Volume of Distribution after the Single Injection of Denosumab

    Measured: up to 3336 hours

  6. Serum type 1 C-telopeptide (CTX1)

    CTX1 level in the serum samples from subjects

    Measured: up to 3336 hours

  7. anti-drug antibodies(ADA)

    ADA Positive Rate after the Single Injection of Denosumab

    Measured: up to 3336 hours

  8. Neutralization antibodies(Nab)

    Neutralizing Antibody Positive Rate after the Single Injection of Denosumab

    Measured: up to 3336 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2023
  2. Study startFeb 2023 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionJul 2024 (estimated)

Why it stopped: Changes in the company's production plan

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Biological: Pre- and Post-change CMAB807X, Xgeva®
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05808673
Sponsor's protocol ID
CMAB807X-001
Status last verified
Feb 2023
First submitted
27 Mar 2023
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Post-change CMAB807X, Pre-change CMAB807X and Xgeva® in people with Healthy Volunteers, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time (time frame: up to 3336 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05808673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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