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Completed

NCT Number: NCT06389942

Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PKUcare Luzhong Hospital

Zibo, Shandong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

9MW3011

Drug

Single dose intravenously on day 1

9MW3011 placebo

Drug

Single dose intravenously on day 1

Primary outcomes

  1. Adverse Event(including serious adverse event)

    Time frame: up to day 99

    The incidence of AEs and SAEs from treatment until the last scheduled follow-up visit

Secondary outcomes

  1. Number of subjects with abnormal vital signs

    Time frame: up to day 99

    Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature.

  2. Number of subjects with abnormal clinically significant results from physical examination

    Time frame: 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.

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

    Time frame: up to day 99

    The examination indicators include heart rate, PR, QRS, uncorrected QT, and QTcF(corrected by Fridericia formula).

  4. Number of subjects with abnormal clinically significant clinical laboratory results

    Time frame: up to day 99

    Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function.

  5. Cmax

    Time frame: up to day 85

    The peak concentration

  6. AUC0-t

    Time frame: up to day 85

    The area under the concentration-time curve from zero to the last time point

  7. AUC0-∞

    Time frame: up to day 85

    The area under the concentration-time curve from zero to infinity

  8. Tmax

    Time frame: up to day 85

    The time to reach peak concentration

  9. λz

    Time frame: up to day 85

    Terminal elimination rate constant

  10. t1/2z

    Time frame: up to day 85

    The terminal elimination half-life

  11. Vz

    Time frame: up to day 85

    The volume of distribution

  12. CL

    Time frame: up to day 85

    Clearance

  13. MRT

    Time frame: up to day 85

    Mean residence time

  14. Pharmacodynamic(PD)parameters-hepcidin

    Time frame: up to day 85

    Change from baseline in hepcidin levels

  15. PD parameters-serum iron

    Time frame: up to day 85

    Change from baseline in serum iron levels

  16. PD parameters-TSAT

    Time frame: up to day 85

    Change from baseline in transferrin saturation(TSAT) levels

  17. Anti-drug antibodies(ADA)

    Time frame: up to day 85

    The incidence of ADA

Sponsors and collaborators

Lead sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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