Trials / Not Yet Recruiting
Not Yet RecruitingNCT05504187
Study to Evaluate Safety, Tolerability and Pharmacodynamics of KP104 in Participants With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus
An Open-label, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 in Subjects With Thrombotic Microangiopathy Secondary to Systemic Lupus Erythematosus
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Kira Pharmacenticals (US), LLC. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KP104 in participants with systemic lupus erythematosus (SLE)-Thrombotic microangiopathy (TMA). The study consists of 2 parts: Part 1 (Dose Optimization) and Part 2 (Proof of Concept). All participants will receive KP104 in combination with standard of care (SOC) for SLE-TMA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KP104 | KP104 will be administered. |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2026-03-01
- Completion
- 2027-04-01
- First posted
- 2022-08-17
- Last updated
- 2024-10-28
Source: ClinicalTrials.gov record NCT05504187. Inclusion in this directory is not an endorsement.