CM336 for Active Sjogren's Syndrome Study
ConditionPrimary Sjögren's Syndrome (pSS)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKeymed Biosciences Co.Ltd
About this trial
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CM336 in adult participants with active primary Sjogren's Syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF), and willing to comply with the study protocol requirements.
Body weight ≥ 45 kg at screening.
Voluntary compliance with the protocol requirements for permitted/prohibited concomitant therapies.
Seropositive for at least one SjD-related autoantibody.
Disqualifiers
Presence of other systemic autoimmune diseases besides primary Sjögren's disease.
Presence of other autoimmune or inflammatory diseases.
Presence of any other medical condition with clinical manifestations overlapping with primary Sjögren's disease or that may interfere with result interpretation.
Presence of active, life-threatening, or organ-threatening SjD complications at screening.
Trial design
Design model
Single group
Treatments tested in this trial
CM336
Biological/VaccineParticipants will receive CM336 via subcutaneous injection in ascending dose cohorts
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: CM336 dose escalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Time frame
Throughout study (Up to 52 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: