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Healthy VolunteersPhase 1NCT05897008

The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and Immunogenicity

A Phase 1 study testing CMAB007 and Xolair in people with Healthy Volunteers, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects. 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?
CMAB007 and Xolair
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteChina
Study dates
7 Feb 2022to 13 Sep 2022
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 ≥50 kg and ≤ 75 kg and BMI ≥20.0 and ≤ 26.0 kg/m2 (both inclusive).
  • 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 informed consent form (name and time) prior to the study.

Who cannot join

  • After medical examination (vital signs, physical examination, electrocardiogram, positive chest X-radiography, abdominal B-ultrasound, and various laboratory examinations including blood routine, urine routine, blood biochemistry and total IgE, etc.), any examination item was judged abnormal by the investigator and had clinical significance.
  • Those who have a history of drug or food allergy, or who have special allergy history (asthma, urticaria, dermatitis eczema, etc.); those who have allergic rhinitis, or are known to be allergic to any component of the test drug or latex (contained in the syringe needle cover).
  • Those who have a history of serious diseases including but not limited to cardiovascular system, respiratory system, digestive system, urogenital system, endocrine system, immune system, mental or nervous system (eg, epilepsy, etc), 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.
  • History of malignant neoplasms within the last 5 years (other than completely resected basal cell or squamous cell carcinoma of the skin in situ).
  • Any one of HBV surface antigen, HIV antibody, HCV antibody and treponema pallidum antibody is positive.
  • Anti-nuclear antibody is positive.
Show all 18Show fewer
  • Fecal parasite test is positive.
  • Those who smoke more than 10 cigarettes per day on average in the 6 months before screening.
  • Alcoholics or regular drinkers within 3 months before the test, i.e. those who drink more than 14 unites of alcohol per week (14 bottles of 360 ml beer or 45 ml spirits with 40% alcohol or 150 ml wine), or whose alcohol breath test is positive.
  • Drug abusers, or use of soft drugs within 3 months prior to screening or hard drugs within 1 year prior the trial, or excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) in the 3 months prior to screening, or positive urine drug screening.
  • Surgery within 4 weeks prior to screening; Or plan to have surgery during the study period.
  • Use of any prescription drug, over-the-counter drug or health product or vaccine within 4 weeks prior to screening, or who plan to receive live vaccine during the study period, or prior use of drug within 5 half-lives, whichever is longer.
  • Those who had lost blood or donated at least 400 mL in the 3 months prior to the screening, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial.
  • Those who have been enrolled in other clinical studies or less than 3 months since the end of the most recent clinical study.
  • Subjects and their partners were not willing to use medically approved contraceptive methods within 6 months of study administration, or partners plan to become pregnant, or subjects plan to donate sperm.
  • Use of anti-IgE mab within 12 months, or any biological agent within 3 months prior to screening.
  • The investigator judges the subject inappropriate to be included in this study or other reasons not eligible to complete the study.
  • Employees or related personnel of the research unit, sponsor or contract research organization.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Xuhui Central Hospital

    Shanghai

Other trials in China

About this study

Official title: Phase I Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of CMAB007 and Xolair in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects

A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.

Read the detailed description

This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study in healthy Chinese male subjects. A total of 114 subjects were planned to be enrolled and randomly assigned to the test group or the control group in a 1:1 ratio. Subjects in both groups received a single subcutaneous injection of CMAB007 or Xolair#Omalizumab# 150 mg, respectively. Subjects in both groups were observed for 106 days after administration to evaluate similarities in PK, PD, safety, and immunogenicity.

Being tested
CMAB007, Xolair

What participants receive

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

  • CMAB007Biological

    for subcutaneous injection only

  • XolairBiological

    for subcutaneous injection only

Study groups in NCT05897008
Study groupRoleWhat they receive
CMAB007Experimental150 mg Subcutaneous injection
Receives: Biological: CMAB007
XolairActive comparator150 mg Subcutaneous injection
Receives: Biological: Xolair

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 Omalizumab

    Measured: up to 2520 hours

  2. Maximum Concentration of Omalizumab

    Maximum Concentration of Omalizumab After the Single Injection of Omalizumab

    Measured: up to 2520 hours

Secondary outcomes (10)

  1. Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2520 Hours

    Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2520 Hours After the Single Injection of Omalizumab

    Measured: up to 2520 hours

  2. Time to Maximum Concentration of Omalizumab

    Time to Maximum Concentration of Omalizumab after the Single Injection of Omalizumab

    Measured: up to 2520 hours

  3. Half time

    Half-time after the Single Injection of Omalizumab

    Measured: up to 2520 hours

  4. Terminal elimination rate constant (λz)

    Terminal elimination rate constant (λz) after the Single Injection of Omalizumab

    Measured: up to 2520 hours

  5. Apparent total body clearance (CL/F)

    Apparent total body clearance (CL/F) after the Single Injection of Omalizumab

    Measured: up to 2520 hours

  6. Apparent total distribution (Vd/F)

    Apparent total distribution (Vd/F) after the Single Injection of Omalizumab

    Measured: up to 2520 hours

  7. Immunoglobulin E levels

    Free IgE in the serum samples from subjects

    Measured: up to 2520 hours

  8. anti-drug antibodies (ADA)

    ADA Positive Rate after the Single Injection of Omalizumab

    Measured: up to 2520 hours

  9. Neutralization antibodies (Nab)

    Neutralizing Antibody Positive Rate after the Single Injection of Omalizumab

    Measured: up to 2520 hours

  10. Percentage and Severity of Participants with Adverse Events

    Total Frequency and Severity of Adverse Events/Serious Adverse Events Within the Whole Time of the Study

    Measured: up to 2520 hours

Timeline

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

  1. First posted9 Jun 2023
  2. Study start7 Feb 2022
  3. Primary completion27 Jun 2022
  4. Study completion13 Sep 2022

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: CMAB007 Biological: Xolair #Omalizumab#
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05897008
Sponsor's protocol ID
CMAB007-002
Status last verified
May 2023
First submitted
31 May 2023
Last updated
12 Jun 2023
Results posted
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 CMAB007 and Xolair 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 4 inclusion and 18 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: finished, as of the sponsor's last update on 12 Jun 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 2520 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 NCT05897008.

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 12 Jun 2023.

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