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
| Type | Name | Description |
|---|---|---|
| DRUG | SLN12140 | 5 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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07387302. Inclusion in this directory is not an endorsement.