Healthy Volunteers (HV)Phase 1NCT07246252
Compare the PK, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in Healthy Adult Male Subjects
A Phase 1 study testing Process-Changed CMAB007 and Xolair (omalizumab) in people with Healthy Volunteers (HV), 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, safety and immunogenicity of two formulations of Omalizumab (Process-Changed 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 (HV)
- What is being tested?
- Process-Changed CMAB007 and Xolair (omalizumab)
- 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
- 28 Mar 2024to 2 Dec 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 ≥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.
- Subjects with a history of clinically significant drug or food allergies, a history of specific allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), allergic rhinitis, or a known allergy to any component of the investigational drug or latex (the syringe needle cover contains latex) as determined by the investigator..
- 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.
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- 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.
- Subjects who have donated blood (including whole blood or component blood) or experienced blood loss of more than 400 mL within 3 months prior to screening, or have received a blood transfusion; or who have donated blood (including component blood) or experienced blood loss of more than 200 mL within 1 month prior to screening; or who plan to donate blood during the study period..
- 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.
About this study
Official title: Phase I Comparison of Pharmacokinetics, Safety, and Immunogenicity of Process-Changed 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, safety and immunogenicity of two formulations of Omalizumab (Process-Changed 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 Process-Changed CMAB007 or Xolair(Omalizumab) 150 mg, respectively. Subjects in both groups were observed for 106 days after administration to evaluate similarities in PK, safety, and immunogenicity.
- Conditions
- Healthy Volunteers (HV)
- Being tested
- Process-Changed CMAB007, Xolair (omalizumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Process-Changed CMAB007Biological
for subcutaneous injection only
Xolair (omalizumab)Biological
for subcutaneous injection only
| Study group | Role | What they receive |
|---|---|---|
| Process-Changed CMAB007 | Experimental | 150 mg Subcutaneous injection Receives: Biological: Process-Changed CMAB007 |
| Xolair | Active comparator | 150 mg Subcutaneous injection Receives: Biological: Xolair (omalizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Maximum Concentration of Omalizumab
Maximum Concentration After the Single Injection of Omalizumab
Measured: up to 2520 hours
Secondary outcomes (9)
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
Time to Maximum Concentration of Omalizumab
Time to Maximum Concentration of Omalizumab after the Single Injection of Omalizumab
Measured: up to 2520 hours
Half time
Half-time after the Single Injection of Omalizumab
Measured: up to 2520 hours
Terminal elimination rate constant (λz)
Terminal elimination rate constant (λz) after the Single Injection of Omalizumab
Measured: up to 2520 hours
Apparent total body clearance (CL/F)
Apparent total body clearance (CL/F) after the Single Injection of Omalizumab
Measured: up to 2520 hours
Apparent total distribution (Vd/F)
Apparent total distribution (Vd/F) after the Single Injection of Omalizumab
Measured: up to 2520 hours
anti-drug antibodies (ADA)
ADA Positive Rate after the Single Injection of Omalizumab
Measured: up to 2520 hours
Neutralization antibodies (Nab)
Neutralizing Antibody Positive Rate after the Single Injection of Omalizumab
Measured: up to 2520 hours
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.
- First posted24 Nov 2025
- Study start28 Mar 2024
- Primary completion30 Sep 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (HV)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Biological: Process-Changed CMAB007 Biological: Xolair
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jingying Jia, Ph.D, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246252
- Sponsor's protocol ID
- CMAB007-004
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Comparison of Pharmacokinetics, Safety, and Immunogenicity of Process-Changed CMAB007 and Xolair in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT07246252
- Acronym / sponsor ID
- CMAB007-004
- Conditions
- Healthy Volunteers (HV)
- 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
- 28 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 24 Nov 2025 (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, safety and immunogenicity of two formulations of Omalizumab (Process-Changed CMAB007 and Xolair) in healthy subjects.
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 Process-Changed CMAB007 or Xolair(Omalizumab) 150 mg, respectively. Subjects in both groups were observed for 106 days after administration to evaluate similarities in PK, safety, and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Biological: Process-Changed CMAB007 Biological: Xolair
| Arm | Type | Receives |
|---|---|---|
| Process-Changed CMAB007 | Experimental | Biological: Process-Changed CMAB007150 mg Subcutaneous injection |
| Xolair | Active comparator | Biological: Xolair (omalizumab)150 mg Subcutaneous injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
- Subjects with a history of clinically significant drug or food allergies, a history of specific allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), allergic rhinitis, or a known allergy to any component of the investigational drug or latex (the syringe needle cover contains latex) as determined by the investigator..
- 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.
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 |
|---|---|---|
| Process-Changed CMAB007for subcutaneous injection only | Biological | Process-Changed CMAB007 |
| Xolair (omalizumab)for subcutaneous injection only | Biological | Xolair |
Primary outcome
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time
Time frame: up to 2520 hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single injection of Omalizumab
Maximum Concentration of Omalizumab
Time frame: up to 2520 hours
Maximum Concentration After the Single Injection of Omalizumab
9 secondary outcomes
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2520 Hours
Time frame: up to 2520 hours
Time to Maximum Concentration of Omalizumab
Time frame: up to 2520 hours
Half time
Time frame: up to 2520 hours
Terminal elimination rate constant (λz)
Time frame: up to 2520 hours
Apparent total body clearance (CL/F)
Time frame: up to 2520 hours
Apparent total distribution (Vd/F)
Time frame: up to 2520 hours
anti-drug antibodies (ADA)
Time frame: up to 2520 hours
Neutralization antibodies (Nab)
Time frame: up to 2520 hours
Percentage and Severity of Participants with Adverse Events
Time frame: up to 2520 hours
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 24 Nov 2025.
- 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.
Jingying Jia, Ph.D principal investigator
Xuhui Central Hospital, Shanghai
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 Process-Changed CMAB007 and Xolair (omalizumab) in people with Healthy Volunteers (HV), 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 24 Nov 2025. 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?
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 24 Nov 2025.