An Evaluation of 9MW1911 Injection in Healthy Subjects

NCT05803902 | Completed Phase 1

• 1 other identifier: 9MW1911-2021-CP101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma; COPD; Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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).

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Secondary Outcomes (5)

• Pharmacokinetics parameters

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• Pharmacokinetics parameters

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• Pharmacokinetics parameters

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• Pharmacokinetics parameters

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• Immunogenicity parameters

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Study Arms (8)

9MW1911 Dose 1

EXPERIMENTAL

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; Drug: Placebo

9MW1911 Dose 2

EXPERIMENTAL

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; Drug: Placebo

9MW1911 Dose 3

EXPERIMENTAL

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; Drug: Placebo

9MW1911 Dose 4

EXPERIMENTAL

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; Drug: Placebo

9MW1911 Dose 5

EXPERIMENTAL

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; Drug: Placebo

9MW1911 Dose 6

EXPERIMENTAL

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; Drug: Placebo

9MW1911 Dose 7

EXPERIMENTAL

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; Drug: Placebo

9MW1911 Dose 8

EXPERIMENTAL

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; Drug: Placebo

Interventions

Experimental drug 9MW1911 DRUG

Experimental drug administered with IV infusion

9MW1911 Dose 1; 9MW1911 Dose 2; 9MW1911 Dose 3; 9MW1911 Dose 4; 9MW1911 Dose 5; 9MW1911 Dose 6; 9MW1911 Dose 7; 9MW1911 Dose 8

Placebo DRUG

Placebo administered with IV infusion

9MW1911 Dose 1; 9MW1911 Dose 2; 9MW1911 Dose 3; 9MW1911 Dose 4; 9MW1911 Dose 5; 9MW1911 Dose 6; 9MW1911 Dose 7; 9MW1911 Dose 8

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).
• \. Female subjects must have a negative β-HCG pregnancy test (Screening and Baseline); Subjects(including their partners) will take effective contraceptive measures voluntarily.

You may not qualify if:

• \. 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 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.
• \. 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.
• \. 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.
• \. Subjects who have lost blood or donated blood ≥200mL within 3 months before screening, or those who plan to donate blood within 3 months.
• \. Subjects positive screening for viral hepatitis (including hepatitis B and C), HIV antibodies, and Treponema pallidum antibodies.
• \. Subjects who paticipated any clinical trial within 3 months before screening.
• \. Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

Sponsors & Collaborators

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

Study Sites (1)

Peking Union Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 7, 2023
• Study Start: December 15, 2021
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (1)