Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject

NCT06389942 | Completed Phase 1

• 1 other identifier: 9MW3011-2022-CP101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Number of subjects with abnormal vital signs

  up to day 99

• Number of subjects with abnormal clinically significant results from physical examination

  up to day 99

• Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters

  up to day 99

• Number of subjects with abnormal clinically significant clinical laboratory results

  up to day 99

• Cmax

  up to day 85

Study Arms (6)

9MW3011 Dose 1

EXPERIMENTAL

Ascending IV doses administered per protocol

Drug: 9MW3011; Drug: 9MW3011 placebo

9MW3011 Dose 2

EXPERIMENTAL

Ascending IV doses administered per protocol

Drug: 9MW3011; Drug: 9MW3011 placebo

9MW3011 Dose 3

EXPERIMENTAL

Ascending IV doses administered per protocol

Drug: 9MW3011; Drug: 9MW3011 placebo

9MW3011 Dose 4

EXPERIMENTAL

Ascending IV doses administered per protocol

Drug: 9MW3011; Drug: 9MW3011 placebo

9MW3011 Dose 5

EXPERIMENTAL

Ascending IV doses administered per protocol

Drug: 9MW3011; Drug: 9MW3011 placebo

9MW3011 Dose 6

EXPERIMENTAL

Ascending IV doses administered per protocol

Drug: 9MW3011; Drug: 9MW3011 placebo

Interventions

9MW3011 DRUG

Single dose intravenously on day 1

9MW3011 Dose 1; 9MW3011 Dose 2; 9MW3011 Dose 3; 9MW3011 Dose 4; 9MW3011 Dose 5; 9MW3011 Dose 6

9MW3011 placebo DRUG

Single dose intravenously on day 1

9MW3011 Dose 1; 9MW3011 Dose 2; 9MW3011 Dose 3; 9MW3011 Dose 4; 9MW3011 Dose 5; 9MW3011 Dose 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18 to 65 years (including 18 and 65 years).
• 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).
• 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.
• Volunteered to participate in this clinical trial, capable of giving written informed consent.

You may not qualify if:

• 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.
• Currently suffering from iron deficiency/Iron deficiency anemia, taking iron supplements and complicated with other diseases related to abnormal iron metabolism.
• 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.
• Subjects who have lost blood or donated blood ≥200mL within 3 months before screening, or those who plan to donate blood within 3 months.
• 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.
• Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

Sponsors & Collaborators

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

Study Sites (1)

PKUcare Luzhong Hospital

Zibo, Shandong, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: April 29, 2024
• Study Start: March 10, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)