An Evaluation of 9MW1911 Injection in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Atopic Dermatitis; COPD
• Intervention / Treatment: Drug: Experimental drug 9MW1911; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Peking Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9MW1911 Dose 1; 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; Experimental drug administered with IV infusion; Drug: Placebo; Placebo administered with IV infusion
Experimental: 9MW1911 Dose 2; 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; Experimental drug administered with IV infusion; Drug: Placebo; Placebo administered with IV infusion
Experimental: 9MW1911 Dose 3; 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; Experimental drug administered with IV infusion; Drug: Placebo; Placebo administered with IV infusion
Experimental: 9MW1911 Dose 4; 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; Experimental drug administered with IV infusion; Drug: Placebo; Placebo administered with IV infusion
Experimental: 9MW1911 Dose 5; 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; Experimental drug administered with IV infusion; Drug: Placebo; Placebo administered with IV infusion
Experimental: 9MW1911 Dose 6; 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; Experimental drug administered with IV infusion; Drug: Placebo; Placebo administered with IV infusion
Experimental: 9MW1911 Dose 7; 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; Experimental drug administered with IV infusion; Drug: Placebo; Placebo administered with IV infusion
Experimental: 9MW1911 Dose 8; 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; Experimental drug administered with IV infusion; Drug: Placebo; Placebo administered with IV infusion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): March 6, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Genetic Diseases, Inborn; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Pulmonary Disease, Chronic Obstructive; Asthma; Dermatitis, Atopic
• Other Study ID Numbers: 9MW1911-2021-CP101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No