The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis.
The secondary objective are to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HLX79 and HLX01, the clinical efficacy, the dynamic changes of biomarkers of HLX79 in combination with HLX01 in the treatment of glomerulonephritis.
The subjects will receive different doses of HLX79 (10, 20, or 30 mg/kg) or placebo, all in combination with HLX01. After the end of the first treatment period, subjects will enter a 20-week follow-up period and then undergo pre-second treatment period assessments. If the investigator determines that the subject does not require the second treatment period, the subject will continue in follow-up until completing the total 48-week follow-up period.
Patients who voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed consent form (ICF), and are willing to follow and able to complete all study procedures.
Male or female, aged 18-75 years (both inclusive) at the time of signing the ICF.
Diagnosed with primary membranous nephropathy (MN) within 5 year prior to screening
Urine protein > 8 g/24 h at screening.(The above 3-month ACEI/ARB treatment observation period is not required)
Pregnant or lactating women, or those with a positive blood pregnancy test prior to randomization.
WOCBP or partners of male subjects who plan to become pregnant during the study.
History of drug or alcohol abuse within 1 year prior to screening.
Malignancy or increased risk of malignancy prior to screening: suspected and/or diagnosed with any malignancy (except for basal cell carcinoma, squamous cell carcinoma of skin in situ, or cervical carcinoma in situ occurring within 5 years prior to screening with no evidence of recurrence after treatment).
Sequential
HLX79 10mg/kg/Placebo+HLX01
DrugSubjects with MN will receive HLX79 10mg/kg or placebo, combine with HLX01 375 mg/m2
HLX79 20mg/kg/Placebo + HLX01
DrugSubjects with MN will receive HLX79 20mg/kg or placebo combined with HLX01 375 mg/m2
HLX79 30mg/kg/placebo+HLX01
DrugSubjects with MN will receive HLX79 30mg/kg or placebo combined with HLX01 375 mg/m2
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Including incidence, nature, and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0, and the incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), abnormal laboratory tests, vital signs, physical examination, and 12-lead ECG
Assessment of safety
Safety: Proportion of subjects with at least one Grade 3 or greater infection-related AE in each dose group according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, and higher grades mean a worse outcome.
Plasma concentrations and PK parameters of HLX79 and HLX01
Peak concentration (Cmax, Cmax, ss)
Plasma concentrations and PK parameters of HLX79 and HLX01
Time to peak (Tmax, Tmax, ss)
Plasma concentrations and PK parameters of HLX79 and HLX01
Area under the concentration-time curve (AUC0-inf, AUC0-t, AUC0-tau, AUCss)
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