Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject

Healthy Clinical Trial

Official title:

A Single-center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity Characteristics of 9MW3011 in Healthy Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06389942
• Other study ID #: 9MW3011-2022-CP101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 10, 2023
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: Mabwell (Shanghai) Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers.

Description:

The single ascending dose(SAD) study will comprise 6 dose cohorts of 8 healthy volunteers each. In each cohort, subjects will be randomized in a 6:2 ratio to receive 9MW3011 or placebo via intravenous infusion.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• 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. Being judged by the investigator to be eligible based on medical history, physical examination, laboratory tests and test related items of inspection or no clinically significant mild abnormalities.

4. Volunteered to participate in this clinical trial, capable of giving written informed consent.

Exclusion Criteria:

1. Nervous/mental, respiratory system, cardiovascular system, digestive system, blood and lymphatic system, endocrine system, skeletal and muscular system , immune system, urinary system diseases , or a family history of severe systemic diseases (including cardiovascular system, digestive system, urinary system, etc.), may affect the health status of the subjects or any other diseases and physiological conditions that may affect the results of the study , judged by the investigator.

2. Currently suffering from iron deficiency/Iron deficiency anemia, taking iron supplements and complicated with other diseases related to abnormal iron metabolism.

3. Subjects who have a history of allergies to monoclonal antibodies or any drug components; those who have a history of allergies to excipients of 9MW3011.

4. Subjects who have lost blood or donated blood =200mL within 3 months before screening, or those who plan to donate blood within 3 months.

5. Positive for hepatitis B virus surface antigen and/or hepatitis B virus e antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or treponema pallidum antibody.

6. Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 9MW3011
Single dose intravenously on day 1
• 9MW3011 placebo
Single dose intravenously on day 1

Locations

Country	Name	City	State
China	PKUcare Luzhong Hospital	Zibo	Shandong

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)	The incidence of AEs and SAEs from treatment until the last scheduled follow-up visit	up to day 99
Secondary	Number of subjects with abnormal vital signs	Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature.	up to day 99
Secondary	Number of subjects with abnormal clinically significant results from physical examination	The physical examinations will include examination of the following: skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, musculoskeletal, nervous system, and other sites of note elicited from the subject.	up to day 99
Secondary	Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters	The examination indicators include heart rate, PR, QRS, uncorrected QT, and QTcF(corrected by Fridericia formula).	up to day 99
Secondary	Number of subjects with abnormal clinically significant clinical laboratory results	Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.	up to day 99
Secondary	Cmax	The peak concentration	up to day 85
Secondary	AUC0-t	The area under the concentration-time curve from zero to the last time point	up to day 85
Secondary	AUC0-8	The area under the concentration-time curve from zero to infinity	up to day 85
Secondary	Tmax	The time to reach peak concentration	up to day 85
Secondary	?z	Terminal elimination rate constant	up to day 85
Secondary	t1/2z	The terminal elimination half-life	up to day 85
Secondary	Vz	The volume of distribution	up to day 85
Secondary	CL	Clearance	up to day 85
Secondary	MRT	Mean residence time	up to day 85
Secondary	Pharmacodynamic(PD)parameters-hepcidin	Change from baseline in hepcidin levels	up to day 85
Secondary	PD parameters-serum iron	Change from baseline in serum iron levels	up to day 85
Secondary	PD parameters-TSAT	Change from baseline in transferrin saturation(TSAT) levels	up to day 85
Secondary	Anti-drug antibodies(ADA)	The incidence of ADA	up to day 85