A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection
Study Details
Study Description
Brief Summary
This is a Phase 1, first time in human study enrolling approximately 42 healthy adult subjects (18-45 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MW14 in healthy adult volunteers administered as a single IV dose compared with placebo, across 5 cohorts. The 5 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 85 days post dose.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 9MW1411 injection
|
Combination Product: 9MW1411 injection
9MW1411 injection
|
| Experimental: 9MW1411 injection placebo
|
Combination Product: 9MW1411 injection placebo
9MW1411 injection placebo
|
Outcome Measures
Primary Outcome Measures
- Adverse Event [12 weeks]
safety evaluation
- Serious Adverse Event [12 weeks]
safety evaluation
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female subjects aged 18 to 45 years (including 18 and 45 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).
-
The medical history, physical examination, clinical laboratory tests and other tests related study show no abnormalities, or abnormalities without clinical significance.
-
Subjects do not have a pregnancy plan, have no sperm and egg donation plans during the screening period and the next 6 months, and take effective contraceptive measures voluntarily.
-
Are willing to follow study procedures, signed informed consent voluntarily, and ensure that he/she will complete the study according to the program requirements.
Exclusion Criteria:
Prior or current medical conditions:
-
Health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities.
-
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.
-
Those who undergone acute infection within 2 weeks prior to screening.
-
Those with abnormalities in pulmonary imaging examination prior to screening and judged to be clinically significant by the investigator.
-
Those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study.
-
Those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness.
-
Those who have a history of drug abuse within 6 months prior to screening.
-
Use of illicit drugs within 3 months prior to screening.
-
Those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 mL), or blood transfusions or use of blood products.
-
Subject (female) who is pregnant or lactating at screening or during the trial.
-
Subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months.
-
Use of any prescription, over-the-counter, or Chinese herbal medicines within 2 weeks prior to screening.
-
Those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study.
-
Those who have smoked more than 5 cigarettes per day within 3 months prior to screening.
-
Those 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 trial.
-
Those who have special dietary requirements and cannot accept a standard diet.
-
Those who have participated in drug or medical devices clinical trials within 3 months prior to screening.
-
Those who have previously used immunosuppressants or monoclonal antibodies for any reason.
-
Those 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.
-
Those with abnormalities in laboratory tests and auxiliary examinations that are judged by the investigator to be clinically significant.
-
Those 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.
-
Female subjects with a positive blood pregnancy test at screening.
-
Alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics [methamphetamine], ketamine, ecstasy [methylenedioxyamphetamine], cannabis [tetrahydrocannabinolate], erythroxylin).
-
Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huashan Hospital Fudan University | Shanghai | Shanghai | China | 200040 |
Sponsors and Collaborators
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Huashan Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9MW1411-2020-CP101