An Evaluation of 9MW1911 Injection in Healthy Subjects

Asthma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05803902
• Other study ID #: 9MW1911-2021-CP101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 29, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2023
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Asthma
• Atopic Dermatitis
• COPD
• Dermatitis

Intervention

Drug:
• Experimental drug 9MW1911
Experimental drug administered with IV infusion
• Placebo
Placebo administered with IV infusion

Locations

Country	Name	City	State
China	Peking Union Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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