SLN12140 in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLinno Pharmaceuticals, Inc.
About this trial
The goal of this clinical trial is to learn if drug SLN12140 works to treat Complement Inhibitor-Naïve Subjects with Paroxysmal Nocturnal Hemoglobinuria in adults. It will also learn about the safety, pharmacokinetic characteristics, and dosing of drug SLN12140.
The study is divided into four phases: screening period, core treatment period, extended dosing period, and follow-up period, and includes two cohorts (Cohorts 1-2), with each cohort enrolling at least 5 treatment-naïve adult PNH subjects for complement inhibitor therapy.
Eligibility criteria
Qualifiers
Adult complement inhibitor naïve PNH patients (age>=18), which is confirmed by flow cytometry evaluation
Must be vaccinated against meningococcal vaccine and pneumococcal vaccine
Disqualifiers
Significant bone marrow failure
Meningitidis infection or unresolved meningococcal disease
Other significant systemic diseases that might have impact on efficacy and safety assessment
Trial design
Treatments tested in this trial
- SLN12140
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov