Healthy
Conditions
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.
Interventions
DRUG9MW3011
Single dose intravenously on day 1
DRUG9MW3011 placebo
Single dose intravenously on day 1
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event(including serious adverse event) | up to day 99 | The incidence of AEs and SAEs from treatment until the last scheduled follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with abnormal clinically significant results from physical examination | 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. |
| Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters | up to day 99 | The examination indicators include heart rate, PR, QRS, uncorrected QT, and QTcF(corrected by Fridericia formula). |
| Number of subjects with abnormal clinically significant clinical laboratory results | up to day 99 | Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function. |
| Cmax | up to day 85 | The peak concentration |
| AUC0-t | up to day 85 | The area under the concentration-time curve from zero to the last time point |
| AUC0-∞ | up to day 85 | The area under the concentration-time curve from zero to infinity |
| Tmax | up to day 85 | The time to reach peak concentration |
| λz | up to day 85 | Terminal elimination rate constant |
| Number of subjects with abnormal vital signs | up to day 99 | Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature. |
| Vz | up to day 85 | The volume of distribution |
| CL | up to day 85 | Clearance |
| MRT | up to day 85 | Mean residence time |
| Pharmacodynamic(PD)parameters-hepcidin | up to day 85 | Change from baseline in hepcidin levels |
| PD parameters-serum iron | up to day 85 | Change from baseline in serum iron levels |
| PD parameters-TSAT | up to day 85 | Change from baseline in transferrin saturation(TSAT) levels |
| Anti-drug antibodies(ADA) | up to day 85 | The incidence of ADA |
| t1/2z | up to day 85 | The terminal elimination half-life |
Countries
China
Outcome results
None listed