Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy
ConditionIgA Nephropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd
About this trial
This study is a multicenter, randomized phase II clinical study to evaluate Efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of CM338 in subjects with Immunoglobulin A(IgA) nephropathy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged 18-75.
Understand the nature of the study and sign the Informed Consent Form voluntarily.
Take effective contraception measures throughout the study period.
Disqualifiers
Used other investigational drugs within 30 days before the first study administration.
With previous history of Human immunodeficiency virus(HIV) infection.
Treponema pallidum antibody positive in screening period.
May have active Mycobacterium tuberculosis infection.
Trial design
Design model
Parallel
Treatments tested in this trial
CM338
Biological/VaccineCM338 injection
Treatment groups
70 Participants
are divided into 3 treatment groupsGroup A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy
To evaluate the incidence of adverse events, including abnormalities of laboratory examination, physical examination, vital signs, 12-lead electrocardiogram (12-ECG) and others.
Time frame
up to week 112Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov