Healthy VolunteersPhase 1NCT04369586
A Phase I Clinical Trial of Meplazumab in Healthy Volunteer
A Phase 1 study testing meplazumab for injection in people with Healthy Volunteers, run by Xijing Hospital at 1 site in China.
Trial summary
This is a single center, double-blinded, placebo-controlled phase I clinical trail in healthy volunteer of meplazumab for injection. The primary objective of this phase I trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and occupancy characteristics of peripheral blood cell receptors of… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- meplazumab for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2020to 20 Nov 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18≤age≤50 years, males or females;
- body weight ≥50 kg, body mass index (BMI) should be within 19.0 and 24.0 (both ends included),
- Vital signs, physical examination, laboratory examination (blood routine, urine routine, blood biochemical, coagulation, etc.) and electrocardiogram are within the normal range, or beyond the normal range, but the researchers determined that the abnormality has no clinical significance (NCS).
- No bad habits, including tobacco addiction (>5 cigarettes per day) or drink addiction (>15 g of alcohol in a day, and more than two days a week for female, or >25 g in a day, and more than two days a week for male; 15 g of alcohol is equivalent to 450 mL beer, 150 mL wine or 50 mL light liquor), no history of drug abuse (defined as the use of illegal drugs);
- No birth plan during the study and within 6 months of completing the test and are willing to use non-hormonal contraceptive measures;
- Have the ability to communicate normally with medical staff and comply with relevant hospital management regulations;
- Understand the study and be willing to participate in the study, and sign an informed consent form. Incompetent subjects, willing and able to comply with all trial requirements.
Who cannot join
- History of allergies to drugs, food, protein or specific allergies (asthma, rubella, eczema dermatitis, etc.);
- Vital signs, physical examination, routine laboratory tests (blood routine, urine routine, blood biochemistry, coagulation, etc.), 12-lead ECG and other abnormalities and clinical significance;
- Positive for SARS-CoV-2 specific IgM and IgG antibodies test;
- Fever within 3 days before medication (body temperature ≥38.0 ℃);
- Pregnant or lactating women;
- Have received or are participating in other clinical trials within 3 months before the screening;
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- Be diagnosed or suspected to have immunodeficiency or autoimmune diseases; undergo immunosuppressive therapy such as anticancer chemotherapy or radiotherapy before the trial, or have received systemic corticosteroid treatment within the past 6 months;
- With a history of acupuncture syncope reaction;
- Positive for HBV surface antigen, anti-HCV antibody, anti-HIV antibody, and syphilis antibody test;
- Tobacco addiction (>5 cigarettes per day) or drink addiction (>15 g of alcohol in a day, and more than two days a week for female, or >25 g in a day, and more than two days a week for male; 15 g of alcohol is equivalent to 450 mL beer, 150 mL wine or 50 mL light liquor), or can not stop smoking and drinking during the study;
- Participated in blood donation or blood loss ≥400mL within 3 months before screening;
- Patients not suitable to participate in this study by the judgment of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: A Single Center, Double-blinded, ,Placebo-controlled Phase I Clinical Trial in Healthy Volunteer to Evaluate Tolerance and Pharmacokinetics of Meplazumab of Injection
This is a single center, double-blinded, placebo-controlled phase I clinical trail in healthy volunteer of meplazumab for injection. The primary objective of this phase I trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and occupancy characteristics of peripheral blood cell receptors of meplazumab in healthy volunteer, and provide a reference for the dosage of meplazumab in phase II clinical trial.
- Conditions
- Healthy Volunteers
- Being tested
- meplazumab for injection, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meplazumab for injectionDrug
single dose: 6 dose level, multiple dose: 0.3mg/kg/dose
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| meplazumab dose 1 | Experimental | 0.06mg/kg for single dose Receives: Drug: meplazumab for injection; Drug: Placebo |
| meplazumab dose 2 | Experimental | 0.12mg/kg for single dose Receives: Drug: meplazumab for injection; Drug: Placebo |
| meplazumab dose 3 | Experimental | 0.2mg/kg for single dose Receives: Drug: meplazumab for injection; Drug: Placebo |
| meplazumab dose 4 | Experimental | 0.3mg/kg for single dose Receives: Drug: meplazumab for injection; Drug: Placebo |
| meplazumab dose 5 | Experimental | 0.42mg/kg for single dose Receives: Drug: meplazumab for injection; Drug: Placebo |
| meplazumab dose 6 | Experimental | 0.56mg/kg for single dose Receives: Drug: meplazumab for injection; Drug: Placebo |
| meplazumab multiple dose | Experimental | 0.3mg/kg for double doses, 1 dose/week Receives: Drug: meplazumab for injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of treatment-related adverse events as assessed by CTCAE v5.0
Nature, incidence, and severity of AEs/SAEs, and the relationship to meplazumab treatment.
Measured: 0-28 days
Secondary outcomes (4)
Pharmacokinetic assessments of meplazumab- AUC0-tn
AUC0-tn
Measured: 0-28 days
Pharmacokinetic assessments of meplazumab- AUC0-∞
AUC0-∞
Measured: 0-28 days
Pharmacokinetic assessments of meplazumab-half life time
Measured: 0-28 days
Pharmacokinetic assessments of meplazumab-Cmax
Maximum observed plasma concentration of meplazumab (Cmax)
Measured: 0-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start25 Apr 2020
- Primary completion18 Aug 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369586
- Sponsor's protocol ID
- MPZ-I-01
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 9 Apr 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 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Double-blinded, ,Placebo-controlled Phase I Clinical Trial in Healthy Volunteer to Evaluate Tolerance and Pharmacokinetics of Meplazumab of Injection
- ClinicalTrials.gov ID
- NCT04369586
- Acronym / sponsor ID
- MPZ-I-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 30 Apr 2020 (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.
This is a single center, double-blinded, placebo-controlled phase I clinical trail in healthy volunteer of meplazumab for injection. The primary objective of this phase I trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and occupancy characteristics of peripheral blood cell receptors of meplazumab in healthy volunteer, and provide a reference for the dosage of meplazumab in phase II clinical trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| meplazumab dose 1 | Experimental | Drug: meplazumab for injection, Drug: Placebo0.06mg/kg for single dose |
| meplazumab dose 2 | Experimental | Drug: meplazumab for injection, Drug: Placebo0.12mg/kg for single dose |
| meplazumab dose 3 | Experimental | Drug: meplazumab for injection, Drug: Placebo0.2mg/kg for single dose |
| meplazumab dose 4 | Experimental | Drug: meplazumab for injection, Drug: Placebo0.3mg/kg for single dose |
| meplazumab dose 5 | Experimental | Drug: meplazumab for injection, Drug: Placebo0.42mg/kg for single dose |
| meplazumab dose 6 | Experimental | Drug: meplazumab for injection, Drug: Placebo0.56mg/kg for single dose |
| meplazumab multiple dose | Experimental | Drug: meplazumab for injection, Drug: Placebo0.3mg/kg for double doses, 1 dose/week |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18≤age≤50 years, males or females;
- body weight ≥50 kg, body mass index (BMI) should be within 19.0 and 24.0 (both ends included),
- Vital signs, physical examination, laboratory examination (blood routine, urine routine, blood biochemical, coagulation, etc.) and electrocardiogram are within the normal range, or beyond the normal range, but the researchers determined that the abnormality has no clinical significance (NCS).
- No bad habits, including tobacco addiction (>5 cigarettes per day) or drink addiction (>15 g of alcohol in a day, and more than two days a week for female, or >25 g in a day, and more than two days a week for male; 15 g of alcohol is equivalent to 450 mL beer, 150 mL wine or 50 mL light liquor), no history of drug abuse (defined as the use of illegal drugs);
- No birth plan during the study and within 6 months of completing the test and are willing to use non-hormonal contraceptive measures;
Key exclusion criteria (12 listed)
- History of allergies to drugs, food, protein or specific allergies (asthma, rubella, eczema dermatitis, etc.);
- Vital signs, physical examination, routine laboratory tests (blood routine, urine routine, blood biochemistry, coagulation, etc.), 12-lead ECG and other abnormalities and clinical significance;
- Positive for SARS-CoV-2 specific IgM and IgG antibodies test;
- Fever within 3 days before medication (body temperature ≥38.0 ℃);
- Pregnant or lactating women;
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 |
|---|---|---|
| meplazumab for injectionsingle dose: 6 dose level, multiple dose: 0.3mg/kg/dose | Drug | meplazumab dose 1, meplazumab dose 2, meplazumab dose 3, meplazumab dose 4, meplazumab dose 5, meplazumab dose 6, meplazumab multiple dose |
| Placeboplacebo | Drug | meplazumab dose 1, meplazumab dose 2, meplazumab dose 3, meplazumab dose 4, meplazumab dose 5, meplazumab dose 6, meplazumab multiple dose |
Primary outcome
Incidence rate of treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 0-28 days
Nature, incidence, and severity of AEs/SAEs, and the relationship to meplazumab treatment.
4 secondary outcomes
Pharmacokinetic assessments of meplazumab- AUC0-tn
Time frame: 0-28 days
Pharmacokinetic assessments of meplazumab- AUC0-∞
Time frame: 0-28 days
Pharmacokinetic assessments of meplazumab-half life time
Time frame: 0-28 days
Pharmacokinetic assessments of meplazumab-Cmax
Time frame: 0-28 days
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 9 Apr 2021.
- Individual participant dataSharing planned: No
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Pain
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 meplazumab for injection in people with Healthy Volunteers, run by Xijing Hospital 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 7 inclusion and 12 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 9 Apr 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?
Incidence rate of treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 0-28 days). 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 9 Apr 2021.