Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 9MW3011; Drug: 9MW3011 placebo

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Zibo, Shandong, China
      • PKUcare Luzhong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9MW3011 Dose 1; Ascending IV doses administered per protocol	Drug: 9MW3011; Single dose intravenously on day 1; Drug: 9MW3011 placebo; Single dose intravenously on day 1
Experimental: 9MW3011 Dose 2; Ascending IV doses administered per protocol	Drug: 9MW3011; Single dose intravenously on day 1; Drug: 9MW3011 placebo; Single dose intravenously on day 1
Experimental: 9MW3011 Dose 3; Ascending IV doses administered per protocol	Drug: 9MW3011; Single dose intravenously on day 1; Drug: 9MW3011 placebo; Single dose intravenously on day 1
Experimental: 9MW3011 Dose 4; Ascending IV doses administered per protocol	Drug: 9MW3011; Single dose intravenously on day 1; Drug: 9MW3011 placebo; Single dose intravenously on day 1
Experimental: 9MW3011 Dose 5; Ascending IV doses administered per protocol	Drug: 9MW3011; Single dose intravenously on day 1; Drug: 9MW3011 placebo; Single dose intravenously on day 1
Experimental: 9MW3011 Dose 6; Ascending IV doses administered per protocol	Drug: 9MW3011; Single dose intravenously on day 1; Drug: 9MW3011 placebo; Single dose intravenously on day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of subjects with abnormal clinically significant clinical laboratory results	Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.	up to day 99
Cmax	The peak concentration	up to day 85
AUC0-t	The area under the concentration-time curve from zero to the last time point	up to day 85
AUC0-∞	The area under the concentration-time curve from zero to infinity	up to day 85
Tmax	The time to reach peak concentration	up to day 85
λz	Terminal elimination rate constant	up to day 85
t1/2z	The terminal elimination half-life	up to day 85
Vz	The volume of distribution	up to day 85
CL	Clearance	up to day 85
MRT	Mean residence time	up to day 85
Pharmacodynamic(PD)parameters-hepcidin	Change from baseline in hepcidin levels	up to day 85
PD parameters-serum iron	Change from baseline in serum iron levels	up to day 85
PD parameters-TSAT	Change from baseline in transferrin saturation(TSAT) levels	up to day 85
Anti-drug antibodies(ADA)	The incidence of ADA	up to day 85

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 9MW3011-2022-CP101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No