Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 9MW3011; Drug: 9MW3011 placebo

• Registration Number: NCT06389942
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-03-10
• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-29
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
9MW3011 Dose 5	9MW3011 placebo	Ascending IV doses administered per protocol
9MW3011 Dose 6	9MW3011	Ascending IV doses administered per protocol
9MW3011 Dose 6	9MW3011 placebo	Ascending IV doses administered per protocol
9MW3011 Dose 2	9MW3011 placebo	Ascending IV doses administered per protocol
9MW3011 Dose 3	9MW3011	Ascending IV doses administered per protocol
9MW3011 Dose 3	9MW3011 placebo	Ascending IV doses administered per protocol
9MW3011 Dose 1	9MW3011	Ascending IV doses administered per protocol
9MW3011 Dose 1	9MW3011 placebo	Ascending IV doses administered per protocol
9MW3011 Dose 4	9MW3011	Ascending IV doses administered per protocol
9MW3011 Dose 4	9MW3011 placebo	Ascending IV doses administered per protocol
9MW3011 Dose 5	9MW3011	Ascending IV doses administered per protocol
9MW3011 Dose 2	9MW3011	Ascending IV doses administered per protocol

Primary Outcome Measures

Name	Time	Method
Adverse Event(including serious adverse event)	up to day 99	The incidence of AEs and SAEs from treatment until the last scheduled follow-up visit

Secondary Outcome Measures

Name	Time	Method
Number of subjects with abnormal vital signs	up to day 99	Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature.
Number of subjects with abnormal clinically significant results from physical examination	up to day 99	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.
Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters	up to day 99	The examination indicators include heart rate, PR, QRS, uncorrected QT, and QTcF(corrected by Fridericia formula).
Number of subjects with abnormal clinically significant clinical laboratory results	up to day 99	Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.
Cmax	up to day 85	The peak concentration
AUC0-t	up to day 85	The area under the concentration-time curve from zero to the last time point
AUC0-∞	up to day 85	The area under the concentration-time curve from zero to infinity
Tmax	up to day 85	The time to reach peak concentration
λz	up to day 85	Terminal elimination rate constant
t1/2z	up to day 85	The terminal elimination half-life
Vz	up to day 85	The volume of distribution
CL	up to day 85	Clearance
MRT	up to day 85	Mean residence time
Pharmacodynamic(PD)parameters-hepcidin	up to day 85	Change from baseline in hepcidin levels
PD parameters-serum iron	up to day 85	Change from baseline in serum iron levels
PD parameters-TSAT	up to day 85	Change from baseline in transferrin saturation(TSAT) levels
Anti-drug antibodies(ADA)	up to day 85	The incidence of ADA

Trial Locations

Locations (1)

PKUcare Luzhong Hospital; 🇨🇳 Zibo, Shandong, China