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Trials / Not Yet Recruiting

Not Yet RecruitingNCT07387302

SLN12140 in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

A Phase II Clinical Study Evaluating SLN12140 in Complement Inhibitor-Naïve Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
Linno Pharmaceuticals, Inc. · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGSLN121405 participants will receive SLN12140 100mg QW for 4 weeks, then 300mg QW for 8 weeks, then 200mg QW for 52 weeks. 5 participants will receive SLN12140 200mg QW for 4 weeks, then 600mg Q4W for 60 weeks

Timeline

Start date
2026-02-10
Primary completion
2026-07-31
Completion
2027-12-31
First posted
2026-02-04
Last updated
2026-02-04

Regulatory

Source: ClinicalTrials.gov record NCT07387302. Inclusion in this directory is not an endorsement.