An Evaluation of 9MW1911 Injection in Healthy Subjects

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05803902

Collaborator

(none)

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma COPD Atopic Dermatitis	Drug: Experimental drug 9MW1911 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 29, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Adverse Event(including serious adverse event) [Day0-Day113]
Evaluate the safety and tolerability of 9MW1911 in healthy subjects, and to determine the possible maximum tolerated dose (MTD).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Hospital	Beijing	Beijing	China	100000

Sponsors and Collaborators

Mabwell (Shanghai) Bioscience Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mabwell (Shanghai) Bioscience Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05803902

Other Study ID Numbers:

9MW1911-2021-CP101

First Posted:

Apr 7, 2023

Last Update Posted:

Apr 7, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dermatitis

Study Results

No Results Posted as of Apr 7, 2023