An Evaluation of 9MW1911 Injection in Healthy Subjects

Study Overview
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Brief Summary
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This study is a randomized, double-blind, dose-escalating phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of 9MW1911 injection in healthy subjects.

Official Title
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A Randomized, Double-blind, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of 9MW1911 Injection in Healthy Subjects

Conditions
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Asthma, COPD, Atopic Dermatitis

Intervention / Treatment
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* Drug: Experimental drug 9MW1911
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1. Male or female subjects aged 18 to 65 years (including 18 and 65 years). 2. 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). 3. Female subjects must have a negative β-HCG pregnancy test (Screening and Baseline); Subjects(including their partners) will take effective contraceptive measures voluntarily. Exclusion Criteria: 1. 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. 2. 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. 3. Subjects with prolonged QTcF interval (> 450 ms) on electrocardiogram (ECG) examination, or family history of prolonged QTc syndrome or sudden death. 4. Subjects received any biological treatment (including all vaccines except the coronavirus vaccine) within 3 months before screening, or planned to take biological treatment during the study period, or received the new coronavirus vaccine within 1 month before screening. 5. Subjects received any prescription drugs or traditional Chinese medicines, including vitamins, trace elements or dietary supplements within 14 days before screening; except for topical products without systemic absorption. 6. Subjects with a history of smoking within 6 months before screening, or unwilling to stop smoking during the study, or willing to use products containing nicotine during the study. 7. Subjects who have lost blood or donated blood ≥200mL within 3 months before screening, or those who plan to donate blood within 3 months. 8. Subjects positive screening for viral hepatitis (including hepatitis B and C), HIV antibodies, and Treponema pallidum antibodies. 9. Subjects who paticipated any clinical trial within 3 months before screening. 10. Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 9MW1911 Dose 1<br>9MW1911 injection ( Dose 1) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. | Drug: Experimental drug 9MW1911<br>* Experimental drug administered with IV infusion<br>Drug: Placebo<br>* Placebo administered with IV infusion<br>|
| Experimental: 9MW1911 Dose 2<br>9MW1911 injection (Dose 2) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. | Drug: Experimental drug 9MW1911<br>* Experimental drug administered with IV infusion<br>Drug: Placebo<br>* Placebo administered with IV infusion<br>|
| Experimental: 9MW1911 Dose 3<br>9MW1911 injection (Dose 3) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. | Drug: Experimental drug 9MW1911<br>* Experimental drug administered with IV infusion<br>Drug: Placebo<br>* Placebo administered with IV infusion<br>|
| Experimental: 9MW1911 Dose 4<br>9MW1911 injection (Dose 4) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. | Drug: Experimental drug 9MW1911<br>* Experimental drug administered with IV infusion<br>Drug: Placebo<br>* Placebo administered with IV infusion<br>|
| Experimental: 9MW1911 Dose 5<br>9MW1911 injection (Dose 5) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. | Drug: Experimental drug 9MW1911<br>* Experimental drug administered with IV infusion<br>Drug: Placebo<br>* Placebo administered with IV infusion<br>|
| Experimental: 9MW1911 Dose 6<br>9MW1911 injection (Dose 6) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. | Drug: Experimental drug 9MW1911<br>* Experimental drug administered with IV infusion<br>Drug: Placebo<br>* Placebo administered with IV infusion<br>|
| Experimental: 9MW1911 Dose 7<br>9MW1911 injection (Dose 7) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. | Drug: Experimental drug 9MW1911<br>* Experimental drug administered with IV infusion<br>Drug: Placebo<br>* Placebo administered with IV infusion<br>|
| Experimental: 9MW1911 Dose 8<br>9MW1911 injection (Dose 8) by intravenous injection once on the first day of treatment. 8 subjects will be enrolled, including 2 subjects for placebo administration. | Drug: Experimental drug 9MW1911<br>* Experimental drug administered with IV infusion<br>Drug: Placebo<br>* Placebo administered with IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event(including serious adverse event) | Evaluate the safety and tolerability of 9MW1911 in healthy subjects, and to determine the possible maximum tolerated dose (MTD). | Day0-Day113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters | Maximum concentration(Cmax) | Day0-Day113 | 
| Pharmacokinetics parameters | The area under the curve (AUC) | Day0-Day113 | 
| Pharmacokinetics parameters | Time at which maximum concentration(Tmax) | Day0-Day113 | 
| Pharmacokinetics parameters | The half life(T1/2) | Day0-Day113 | 
| Immunogenicity parameters | The incidence of ADAs against 9MW1911 during the study will be summarized | Day0-Day113 |