AsthmaPhase 1NCT04778137
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety
A Phase 1 study testing Omalizumab in people with Asthma, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics and safety 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
- Asthma
- What is being tested?
- Omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 25 May 2021
- 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 subject between the ages of 18 and 45 years.
- Subject with a body weight of ≥50 kg and ≤ 75kg and a BMI between 19.0~26.0 kg/m2 (both inclusive).
Who cannot join
- subject has a medical history and/or current presence of disease
- subject has undergone surgery within three months before signing the informed consent;
- 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 630 ml spirits with 40% alcohol), or whose alcohol breath test is positive;
- Those who have used soft drugs within 3 months prior to signing the informed consent or hard drugs within 1 year prior the trial; those who have positive drug abuse test results;
- Those who smoke more than 10 cigarettes per day on average in the 6 months before signing the informed consent; or those who have positive nocotine results;
- Those who have a history of drug or food allergy, or who have special allergy history (asthma, urticaria, 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);
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- Those who drinking too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 ml) every day;
- Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, Traditional Chinese medicine, etc.) and health care products within 4 weeks befor signing the informed consent;
- Those who have a blood donation over 400 ml within 3 months, or 200 ml within 1 month before signing the informed consent, or plan to donate blood during the trail;
- Those who accept any biological drugs within 3 months, or anti-IgE biological drugs within 12 months before signing the informed consent;
- Those who plan to donate sperm within 6 months after the administration of the test drug;
- Participants in other clinical trails within 3 months before signing the informed consent;
- Any one of HIV antibody, HBsAg, HBeAg, HBcAg, HCV antibody and Treponerma pallidum antibody is positive;
- The results of medical examination (ECG, X-ray, B-ultrasonic, physical and laboratory examination) are clinical significant abnormalities according to the judgment of the researcher;
- Anti-nuclear antibody or fecal parasite test is positive;
- Those who have undergone surgery within 1 months before signing the informed consent, or plan to undergo surgery during the trail period;
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics and safety of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.
- Conditions
- Asthma
- Being tested
- Omalizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Biological: CMAB007 Biological: Xolair
| Study group | Role | What they receive |
|---|---|---|
| CMAB007 | Experimental | 75mg×2 Receives: Drug: Omalizumab |
| Xolair | Active comparator | 150mg Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Outcome Measures [AUC0-inf]
Area Under the Concentration-time Curve from Time zero to infinity (AUC0-inf) of CMAB007 and Xolair in healthy subjects.
Measured: up to day 106
Pharmacokinetic Outcome Measures [Cmax]
Maximum serum concentration (Cmax) of CMAB007 and Xolair in healthy subjects.
Measured: up to day 106
Secondary outcomes (9)
Pharmacokinetic Outcome Measures [Tmax]
Time to Cmax (Tmax) of CMAB007 and Xolair in healthy subjects
Measured: up to day 106
Pharmacokinetic Outcome Measures [t1/2]
Terminal half-life (t1/2) of CMAB007 and Xolair in healthy subjects
Measured: up to day 106
Pharmacokinetic Outcome Measures [λz]
Terminal elimination rate constant (λz) of CMAB007 and Xolair in healthy subjects
Measured: up to day 106
Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)]
Apparent total body clearance (CL/F) of CMAB007 and Xolair in healthy subjects
Measured: up to day 106
Pharmacodynamics [IgE levels]
Free IgE and total IgE levels (the sum of free and omalizumab-bound IgE) in the serum samples from subjects
Measured: up to day 106
Incidence of Treatment-Emergent Adverse Events [Safety]
Treatment-Emergent Adverse Events (TEAEs) of CMAB007 and Xolair in healthy subjects
Measured: up to day 106
Pharmacokinetic Outcome Measures [AUC0-t]
Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-t) of CMAB007 and Xolair in healthy subjects.
Measured: up to day 106
Pharmacokinetic Outcome Measures [Vd/F]
Apparent total distribution (Cd/F) of CMAB007 and Xolair in healthy subjects
Measured: up to day 106
Immunogenicity
the Immunogenicity of CMAB007 and Xolair in healthy subjects.
Measured: up to day 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Dec 2020
- Primary completion26 Apr 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778137
- Sponsor's protocol ID
- CMAB007-001
- Status last verified
- Jan 2021
- First submitted
- 26 Feb 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD and Safety
- ClinicalTrials.gov ID
- NCT04778137
- Acronym / sponsor ID
- CMAB007-001
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics and safety of two formulations of Omalizumab (CMAB007 and Xolair) in healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMAB007 | Experimental | Drug: Omalizumab75mg×2 |
| Xolair | Active comparator | Drug: Omalizumab150mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subject between the ages of 18 and 45 years.
- Subject with a body weight of ≥50 kg and ≤ 75kg and a BMI between 19.0~26.0 kg/m2 (both inclusive).
Key exclusion criteria (16 listed)
- subject has a medical history and/or current presence of disease
- subject has undergone surgery within three months before signing the informed consent;
- 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 630 ml spirits with 40% alcohol), or whose alcohol breath test is positive;
- Those who have used soft drugs within 3 months prior to signing the informed consent or hard drugs within 1 year prior the trial; those who have positive drug abuse test results;
- Those who smoke more than 10 cigarettes per day on average in the 6 months before signing the informed consent; or those who have positive nocotine results;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmalizumabBiological: CMAB007 Biological: Xolair | Drug | CMAB007, Xolair |
Primary outcome
Pharmacokinetic Outcome Measures [AUC0-inf]
Time frame: up to day 106
Area Under the Concentration-time Curve from Time zero to infinity (AUC0-inf) of CMAB007 and Xolair in healthy subjects.
Pharmacokinetic Outcome Measures [Cmax]
Time frame: up to day 106
Maximum serum concentration (Cmax) of CMAB007 and Xolair in healthy subjects.
9 secondary outcomes
Pharmacokinetic Outcome Measures [Tmax]
Time frame: up to day 106
Pharmacokinetic Outcome Measures [t1/2]
Time frame: up to day 106
Pharmacokinetic Outcome Measures [λz]
Time frame: up to day 106
Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)]
Time frame: up to day 106
Pharmacodynamics [IgE levels]
Time frame: up to day 106
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: up to day 106
Pharmacokinetic Outcome Measures [AUC0-t]
Time frame: up to day 106
Pharmacokinetic Outcome Measures [Vd/F]
Time frame: up to day 106
Immunogenicity
Time frame: up to day 106
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omalizumab in people with Asthma, 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 2 inclusion and 16 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 11 Oct 2021. 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?
Pharmacokinetic Outcome Measures [AUC0-inf] (time frame: up to day 106). 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?
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 11 Oct 2021.