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An Evaluation of 9MW1911 Injection in Healthy Subjects

Primary Purpose

Asthma, COPD, Atopic Dermatitis

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Experimental drug 9MW1911
Placebo
Sponsored by
Mabwell (Shanghai) Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Peking Union Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

9MW1911 Dose 1

9MW1911 Dose 2

9MW1911 Dose 3

9MW1911 Dose 4

9MW1911 Dose 5

9MW1911 Dose 6

9MW1911 Dose 7

9MW1911 Dose 8

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2022
Last Updated
April 5, 2023
Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05803902
Brief Title
An Evaluation of 9MW1911 Injection in Healthy Subjects
Official Title
A Randomized, Double-blind, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of 9MW1911 Injection in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 29, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mabwell (Shanghai) Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD, Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
9MW1911 Dose 1
Arm Type
Experimental
Arm Description
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.
Arm Title
9MW1911 Dose 2
Arm Type
Experimental
Arm Description
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.
Arm Title
9MW1911 Dose 3
Arm Type
Experimental
Arm Description
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.
Arm Title
9MW1911 Dose 4
Arm Type
Experimental
Arm Description
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.
Arm Title
9MW1911 Dose 5
Arm Type
Experimental
Arm Description
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.
Arm Title
9MW1911 Dose 6
Arm Type
Experimental
Arm Description
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.
Arm Title
9MW1911 Dose 7
Arm Type
Experimental
Arm Description
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.
Arm Title
9MW1911 Dose 8
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Experimental drug 9MW1911
Intervention Description
Experimental drug administered with IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered with IV infusion
Primary Outcome Measure Information:
Title
Adverse Event(including serious adverse event)
Description
Evaluate the safety and tolerability of 9MW1911 in healthy subjects, and to determine the possible maximum tolerated dose (MTD).
Time Frame
Day0-Day113
Secondary Outcome Measure Information:
Title
Pharmacokinetics parameters
Description
Maximum concentration(Cmax)
Time Frame
Day0-Day113
Title
Pharmacokinetics parameters
Description
The area under the curve (AUC)
Time Frame
Day0-Day113
Title
Pharmacokinetics parameters
Description
Time at which maximum concentration(Tmax)
Time Frame
Day0-Day113
Title
Pharmacokinetics parameters
Description
The half life(T1/2)
Time Frame
Day0-Day113
Title
Immunogenicity parameters
Description
The incidence of ADAs against 9MW1911 during the study will be summarized
Time Frame
Day0-Day113

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking Union Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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An Evaluation of 9MW1911 Injection in Healthy Subjects

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