drugset / Trial / NCT00927459
Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol
RandomizedSingle-groupSingle-blindTreatment
Summary
This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study in male and female subjects with high cholesterol. A maximum of 32 subjects is planned for enrollment in this study.
Timeline
- Start
- 2009-06
- Primary completion
- 2009-12
- Completion
- 2010-01
Outcome
Outcome not reported
Stopped: “Potential for immune stimulation to interfere with further dose escalation.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PRO-040201 | Small interfering RNA (siRNA) | — | Intravenous |
Indications
No indication recorded.