Granulomatosis With PolyangiitisEarly Phase 1NCT05353179
Study on Pharmacokinetics of Meperizumab Injection and NUCALA® in Healthy Male Volunteers
A Early Phase 1 study testing Meperizumab injection and NUCALA® in people with Granulomatosis With Polyangiitis and Hemophagocytic Syndrome, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The trial was designed as a single-center, randomized, double-blind, single-dose parallel controlled phase I study to evaluate the similarity of pharmacokinetics and safety of Meperizumab injection and NUCALA® in healthy male volunteers. The plan is to enroll 88 healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Granulomatosis With Polyangiitis, Hemophagocytic Syndrome
- What is being tested?
- Meperizumab injection and NUCALA®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- Jun 2022to Oct 2022
- Phase
- Early 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1 Before the study, the informed consent was signed and the content, process and possible adverse reactions of the test were fully understood;
- 2 Able to complete the research according to the requirements of the test protocol;
- 3 Male subjects aged 18-55 (18 and 55 included);
- 4 Body weight ≥ 50 kg ≤90 kg, body mass index (BMI) ≥ 19 ≤ 26kg/m2;
- 5 Health status: No mental disorders, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities;
- 6 Subjects had no pregnancy plans and voluntarily used effective contraception for at least 6 months from 2 weeks prior to self-medication to their last use of study medication.
Who cannot join
- 1 Previous neuropsychiatric, respiratory, cardiovascular, digestive, hemolymph, hepatic and renal dysfunction, endocrine, skeletal and musculoskeletal disorders, or other diseases that the investigator judged might affect drug metabolism or safety;
- 2 Known allergy to meperizumab or its excipients;
- 3 Known history of allergic disease or allergy or history of asthma disease;
- 4 Prior treatment with meperizumab or an IL-5 receptor inhibitor, or other antibody or protein drugs that target the IL-5 receptor;
- 5 Who received any live viral vaccines within 2 months prior to infusion of the study drug, or who needed to be vaccinated between the screening period and the end of the study, who used the study drug within 12 months prior to administration of the study drug or planned to receive any monoclonal antibodies or biologic drugs within 12 months after administration of the study drug;
- 6 Patients who have unhealed wounds, ulcers or fractures, or who underwent major surgery within 3 months prior to infusion of the study drug, or who are expected to undergo major surgery within 2 months after study completion;
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- 7 Any prescription, over-the-counter, vitamin product or herbal medicine used in the 2 weeks prior to taking the study drug;
- 8 Abnormal and clinically significant examinations during screening period;
- 9 Blood donation or significant blood loss within 3 months prior to taking the study drug (\& GT; 450 ml);
- 10 Participated in any drug clinical trials within 3 months prior to taking the study drug;
- 11 Those who smoked more than 5 cigarettes a day 3 months before the experiment;
- 12 History of alcohol abuse (14 units of alcohol per week: 1 unit =360mL beer or 45mL 40% spirits or 150mL wine);
- 13 Those who are screened positive for drugs or have a history of drug abuse in the past five years or have used drugs in the three months prior to the test;
- 14 Screening positive for hepatitis (including hepatitis B and C), acquired immunodeficiency syndrome(AIDS) and syphilis;
- 15 The subject is unable to complete the test due to personal reasons;
- 16 Conditions that other researchers consider inappropriate for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130021
About this study
Official title: Phase I, Single-center, Randomized, Double-blind, Single-dose, Parallel Comparison of Pharmacokinetic and Safety Similarities Between Meperizumab Injection and NUCALA® in Healthy Male Volunteers
The trial was designed as a single-center, randomized, double-blind, single-dose parallel controlled phase I study to evaluate the similarity of pharmacokinetics and safety of Meperizumab injection and NUCALA® in healthy male volunteers.
The plan is to enroll 88 healthy subjects. After signing the written informed consent voluntarily, the subjects will undergo a series of examinations and information collection to determine whether they meet the inclusion criteria. The qualified subjects will be randomized and administered. Biological samples were collected and safety checked before and after administration according to protocol requirements. Adverse events occurred during the trial were collected, and the combination of drug use and non-drug treatment were asked and recorded in detail.
When the 90% confidence interval of geometric mean ratio of the main pharmacokinetic parameters of Meperizumab injection and NUCALA® was within the range of 80.00%-125.00%, it was proved that the pharmacokinetic characteristics of the two were similar.
- Being tested
- Meperizumab injection, NUCALA®
- Medical subject headings
- Granulomatosis with Polyangiitis, Lymphohistiocytosis, Hemophagocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meperizumab injectionDrug
Meperizumab injection is a humanized monoclonal antibody of IgG1 injection
NUCALA®Drug
NUCALA® is a humanized monoclonal antibody of IgG1 injection
| Study group | Role | What they receive |
|---|---|---|
| Meperizumab injection | Experimental | Subcutaneous injection of meperizumab once Receives: Drug: Meperizumab injection |
| NUCALA® | Active comparator | Subcutaneous injection of NUCALA® once Receives: Drug: NUCALA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration(Cmax)
Peak maximum plasma drug concentration
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Area under drug concentration - time curve(AUC0-t)
Area under the curve from zero to the lowest detectable blood drug concentration
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Secondary outcomes (14)
The area under the curve extrapolating from zero to infinity(AUC0-∞)
Area under the curve from zero to infinity
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Peak concentration time(Tmax)
Time to reach maximum plasma concentration after dosing
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
half-life(T1/2)
The time it takes for serum drug concentrations to drop by half
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Elimination rate constant(λz)
The slope of the terminal segment of a semi-logarithmic curve
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Residual area percentage(AUC%Extrap)
The percentage of the difference between AUC0-∞ and AUC0-t as a percentage of AUC0-t
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Apparent clearance(CL/F)
Percentage of the body that eliminates organ-scavenging drugs
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Apparent volume of distribution(Vd/F)
Apparent volume of distribution after non-intravenous administration
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Physical examination
The doctor will percuss, look, and question the subject, and record any abnormalities in the skin, spine, or limbs
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Body temperature
Abnormal body temperature
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Pulse
Abnormal pulse
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Blood pressure
Abnormal blood pressure
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Electrocardiogram(ECG) QT Interval
Abnormal ECG QT Interval
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Anti-drug antibody(ADA)
ADA positive
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Neutralizing antibody(NAb)
NAb positive
Measured: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study startJun 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353179
- Sponsor's protocol ID
- TQC3566-I-01
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Single-center, Randomized, Double-blind, Single-dose, Parallel Comparison of Pharmacokinetic and Safety Similarities Between Meperizumab Injection and NUCALA® in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT05353179
- Acronym / sponsor ID
- TQC3566-I-01
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 29 Apr 2022 (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.
The trial was designed as a single-center, randomized, double-blind, single-dose parallel controlled phase I study to evaluate the similarity of pharmacokinetics and safety of Meperizumab injection and NUCALA® in healthy male volunteers.
The plan is to enroll 88 healthy subjects. After signing the written informed consent voluntarily, the subjects will undergo a series of examinations and information collection to determine whether they meet the inclusion criteria. The qualified subjects will be randomized and administered. Biological samples were collected and safety checked before and after administration according to protocol requirements. Adverse events occurred during the trial were collected, and the combination of drug use and non-drug treatment were asked and recorded in detail.
When the 90% confidence interval of geometric mean ratio of the main pharmacokinetic parameters of Meperizumab injection and NUCALA® was within the range of 80.00%-125.00%, it was proved that the pharmacokinetic characteristics of the two were similar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meperizumab injection | Experimental | Drug: Meperizumab injectionSubcutaneous injection of meperizumab once |
| NUCALA® | Active comparator | Drug: NUCALA®Subcutaneous injection of NUCALA® once |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 1 Before the study, the informed consent was signed and the content, process and possible adverse reactions of the test were fully understood;
- 2 Able to complete the research according to the requirements of the test protocol;
- 3 Male subjects aged 18-55 (18 and 55 included);
- 4 Body weight ≥ 50 kg ≤90 kg, body mass index (BMI) ≥ 19 ≤ 26kg/m2;
- 5 Health status: No mental disorders, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities;
Key exclusion criteria (16 listed)
- 1 Previous neuropsychiatric, respiratory, cardiovascular, digestive, hemolymph, hepatic and renal dysfunction, endocrine, skeletal and musculoskeletal disorders, or other diseases that the investigator judged might affect drug metabolism or safety;
- 2 Known allergy to meperizumab or its excipients;
- 3 Known history of allergic disease or allergy or history of asthma disease;
- 4 Prior treatment with meperizumab or an IL-5 receptor inhibitor, or other antibody or protein drugs that target the IL-5 receptor;
- 5 Who received any live viral vaccines within 2 months prior to infusion of the study drug, or who needed to be vaccinated between the screening period and the end of the study, who used the study drug within 12 months prior to administration of the study drug or planned to receive any monoclonal antibodies or biologic drugs within 12 months after administration of the study drug;
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 |
|---|---|---|
| Meperizumab injectionMeperizumab injection is a humanized monoclonal antibody of IgG1 injection | Drug | Meperizumab injection |
| NUCALA®NUCALA® is a humanized monoclonal antibody of IgG1 injection | Drug | NUCALA® |
Primary outcome
Peak concentration(Cmax)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Peak maximum plasma drug concentration
Area under drug concentration - time curve(AUC0-t)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Area under the curve from zero to the lowest detectable blood drug concentration
14 secondary outcomes
The area under the curve extrapolating from zero to infinity(AUC0-∞)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Peak concentration time(Tmax)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
half-life(T1/2)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Elimination rate constant(λz)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Residual area percentage(AUC%Extrap)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Apparent clearance(CL/F)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Apparent volume of distribution(Vd/F)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Physical examination
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Body temperature
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Pulse
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Blood pressure
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Electrocardiogram(ECG) QT Interval
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Anti-drug antibody(ADA)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Neutralizing antibody(NAb)
Time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Meperizumab injection and NUCALA® in people with Granulomatosis With Polyangiitis and Hemophagocytic Syndrome, run by Chia Tai Tianqing Pharmaceutical Group 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 6 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: status not confirmed, as of the sponsor's last update on 29 Apr 2022. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haimiao Yang, Master (0431-86177635, czfyyq728@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration(Cmax) (time frame: 0 hours before administration (within 60 minutes before administration) to 2016 hours after administration). 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 29 Apr 2022.