Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject

Mabwell Bioscience

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 9MW3011; Drug: 9MW3011 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06389942

9MW3011-2022-CP101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 6 patient groups

9MW3011 Dose 1

Experimental group

Description:

Ascending IV doses administered per protocol

Treatment:

Drug: 9MW3011 placebo

Drug: 9MW3011

9MW3011 Dose 2

Experimental group

Description:

Ascending IV doses administered per protocol

Treatment:

Drug: 9MW3011 placebo

Drug: 9MW3011

9MW3011 Dose 3

Experimental group

Description:

Ascending IV doses administered per protocol

Treatment:

Drug: 9MW3011 placebo

Drug: 9MW3011

9MW3011 Dose 4

Experimental group

Description:

Ascending IV doses administered per protocol

Treatment:

Drug: 9MW3011 placebo

Drug: 9MW3011

9MW3011 Dose 5

Experimental group

Description:

Ascending IV doses administered per protocol

Treatment:

Drug: 9MW3011 placebo

Drug: 9MW3011

9MW3011 Dose 6

Experimental group

Description:

Ascending IV doses administered per protocol

Treatment:

Drug: 9MW3011 placebo

Drug: 9MW3011