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Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject

NCT ID: NCT06389942

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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9MW3011 Dose 1

Ascending IV doses administered per protocol

Group Type EXPERIMENTAL

9MW3011

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 placebo

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 Dose 2

Ascending IV doses administered per protocol

Group Type EXPERIMENTAL

9MW3011

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 placebo

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 Dose 3

Ascending IV doses administered per protocol

Group Type EXPERIMENTAL

9MW3011

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 placebo

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 Dose 4

Ascending IV doses administered per protocol

Group Type EXPERIMENTAL

9MW3011

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 placebo

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 Dose 5

Ascending IV doses administered per protocol

Group Type EXPERIMENTAL

9MW3011

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 placebo

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 Dose 6

Ascending IV doses administered per protocol

Group Type EXPERIMENTAL

9MW3011

Intervention Type DRUG

Single dose intravenously on day 1

9MW3011 placebo

Intervention Type DRUG

Single dose intravenously on day 1

Interventions

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9MW3011

Single dose intravenously on day 1

Intervention Type DRUG

9MW3011 placebo

Single dose intravenously on day 1

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PKUcare Luzhong Hospital

Zibo, Shandong, China

Site Status

Countries

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China

Other Identifiers

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9MW3011-2022-CP101

Identifier Type: -

Identifier Source: org_study_id