- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05170243
A Clinical Study in Healthy Subjects to Evaluate 9MW1911 Injection
December 4, 2023 updated by: Mabwell (Shanghai) Bioscience Co., Ltd.
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Immunogenicity of a Single Dose of 9MW1911 Injection in Healthy Subjects
This is a Phase 1, randomized, placebo-controlled study, enrolling approximately 38 healthy adult subjects (18-65 yrs).
The purpose of this study is to evaluate the safety, tolerability and PK of single ascending dose of 9MW1911 administered intravenously (IV) in healthy adult volunteers.
All subjects will be followed up for safety from the time of Informed Consent through 113 days post dose.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zeng Shaoqing, Bachelor
- Phone Number: +86 021-58585793
- Email: shaoqing.zeng@mabwell.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200540
- Shanghai Public Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants are willing to follow study procedures and sign informed consent voluntarily.
- Male or female subjects aged 18 to 65 years (including 18 and 65 years).
- Weight≥50.0 kg for males, or weight≥45.0 kg for females, and body mass index (BMI) in the range of 19.0 ~ 26.0 kg/m2 (including cut-off value).
- Female subjects must have a negative β-HCG pregnancy test (Screening and Baseline); Subjects(including their partners) will take effective contraceptive measures voluntarily;Subjects have neither pregnancy plans nor sperm or egg donation plans during the screening period and the next 6 months.
Exclusion Criteria:
- Subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment.
- The clinical laboratory tests show any clinical abnormalities, or abnormalities with clinical significance(including but not limited to diseases of digestive tract, kidney, liver, nervous system, blood, endocrine system, cancer, lung, immune system, mental, heart),and judged by the investigator to affect participation in this study.
- Subjects with prolonged QTcF interval (> 450 ms) on electrocardiogram (ECG) examination, or family history of prolonged QTc syndrome or sudden death.
- Subjects (female) who is pregnant or lactating at screening or during the trial.
- Subjects who have previously used immunosuppressants or monoclonal antibodies for any reason.
- Subjects who used any prescription, over-the-counter, or Chinese herbal medicines within 2 weeks prior to screening.
- Subjects who received any vaccinations within 4 weeks prior to screening, or are scheduled to receive a vaccination during the study.
- Subjects who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the study.
- Subjects who have a history of drug abuse within 6 months prior to screening.
- Subjects who have used illicit drugs within 3 months prior to screening.
- Subjects who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the study.
- Subjects who have smoked more than 5 cigarettes per day within 3 months prior to screening, or who cannot abstain from cigarette product during the study.
- Subjects who have participated in drug or medical devices clinical trials within 3 months prior to screening.
- Subjects who donated or lost blood ≥ 200 mL within 3 months prior to screening, or plan to donate blood within 3 months.
- Subjects whose alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics [methamphetamine], ketamine, ecstasy [methylenedioxyamphetamine], cannabis [tetrahydrocannabinolate]).
- Subjects who have one or more clinically significant tests of hepatitis B virological markers, hepatitis C virus antibodies, anti-human immunodeficiency virus antibodies, or anti-Treponema pallidum-specific antibodies.
- Subjects who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness.
- Subjects who show insufficient communication, understanding and cooperation, or poor compliance to ensure observation and follow-up as required by the protocol.
- Subjects with abnormal vital signs with clinical significance: diastolic blood pressure≤50 mmHg or ≥90 mmHg, pulse≤50 beats/min or ≥100 beats/min, body temperature (ear temperature) <35.5°C or >37.5°C, respiration>20 breaths/min. The specific situation will be comprehensively determined by the investigator.
- Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 9MW1911 Injection
Experimental drug administered IV infusion
|
Single dose intravenously on day 1
|
Placebo Comparator: 9MW1911 Injection Placebo
Placebo administered IV infusion
|
Single dose of matching placebo intravenously on day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Event(including serious adverse event)
Time Frame: up to day 113
|
The incidence of AEs (adverse events) and SAEs (serious adverse events) from treatment until the last scheduled follow-up visit
|
up to day 113
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK parameters
Time Frame: up to day 113
|
Maximum concentration(Cmax)
|
up to day 113
|
PK parameters
Time Frame: up to day 113
|
The area under the curve (AUC)
|
up to day 113
|
PK parameters
Time Frame: up to day 113
|
Time at which maximum concentration(Tmax)
|
up to day 113
|
PK parameters
Time Frame: up to day 113
|
The half life(T1/2)
|
up to day 113
|
Incidence of ADAs Against 9MW1911
Time Frame: up to day 113
|
The incidence of ADAs against 9MW1911 during the study will be summarized
|
up to day 113
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Wang Shuhai, Ph.D, Mabwell (Shanghai) Bioscience Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2022
Primary Completion (Actual)
July 3, 2022
Study Completion (Actual)
October 28, 2022
Study Registration Dates
First Submitted
December 12, 2021
First Submitted That Met QC Criteria
December 22, 2021
First Posted (Actual)
December 27, 2021
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9MW1911-2021-CP102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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