Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus
Summary
The purpose of this study is to determine the safety, tolerability and efficacy of intranasal ALN-RSV01 versus placebo, administered once daily for 5 days to a healthy male volunteers experimentally inoculated with RSV
Timeline
- Start
- 2007-07
- Primary completion
- —
- Completion
- 2007-11
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
release “Alnylam Achieves First Human Proof of Concept for an RNAi Therapeutic with GEMINI Study - Phase II Clinical Trial of ALN-RSV01 Demonstrates Statistically Significant Anti-Viral Efficacy” reads as met primary endpoint alnylam.com ↗
release “results from the company's GEMINI trial in subjects experimentally infected with RSV showed statistically significant anti-viral efficacy for ALN-RSV01 as compared with placebo.” reads as met primary endpoint alnylam.com ↗
release “anti-viral activity of ALN-RSV01 was demonstrated in the company's Phase II GEMINI study” reads as met primary endpoint alnylam.com ↗
release “In the ITTc analysis, ALN-RSV01 narrowly missed the primary endpoint of new or progressive BOS at 180 days.” reads as missed primary endpoint alnylam.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASVASIRAN SODIUM | Small interfering RNA (siRNA) | — | Intranasal |