Clinical trial NCT06389942: Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Event(including serious adverse event)
timeFrame: up to day 99
Secondary outcomes:
measure: Number of subjects with abnormal vital signs
timeFrame: up to day 99
measure: Number of subjects with abnormal clinically significant results from physical examination
timeFrame: up to day 99
measure: Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
timeFrame: up to day 99
measure: Number of subjects with abnormal clinically significant clinical laboratory results
timeFrame: up to day 99
measure: Cmax
timeFrame: up to day 85
measure: AUC0-t
timeFrame: up to day 85
measure: AUC0-∞
timeFrame: up to day 85
measure: Tmax
timeFrame: up to day 85
measure: λz
timeFrame: up to day 85
measure: t1/2z
timeFrame: up to day 85
measure: Vz
timeFrame: up to day 85
measure: CL
timeFrame: up to day 85
measure: MRT
timeFrame: up to day 85
measure: Pharmacodynamic(PD)parameters-hepcidin
timeFrame: up to day 85
measure: PD parameters-serum iron
timeFrame: up to day 85
measure: PD parameters-TSAT
timeFrame: up to day 85
measure: Anti-drug antibodies(ADA)
timeFrame: up to day 85
Other outcomes:
Locations:
city: Zibo
country: China
facility: PKUcare Luzhong Hospital
state: Shandong
Study officials:
References: