Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00999531 | A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy Volunteers | PHASE1 | COMPLETED | 24 | — | — | Oct 1, 2009 | Mar 1, 2010 | Mar 10, 2010 | 1 | Australia |
| NCT00951522 | A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers | PHASE1 | COMPLETED | 15 | — | — | Sep 1, 2009 | Sep 1, 2009 | Sep 25, 2009 | 1 | Australia |
| NCT00800579 | Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers | PHASE1 | COMPLETED | 12 | — | — | Nov 1, 2008 | Feb 1, 2009 | Oct 21, 2009 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | GS-9411 9.6 mg |
| 2 | EXPERIMENTAL | GS-9411 4.8 mg |
| 3 | EXPERIMENTAL | GS-9411 2.4 mg |
| 4 | PLACEBO_COMPARATOR | Saline Placebo |
| 5 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| GS-9411 | DRUG | Inhaled GS-9411 dissolved in sterile saline |
| Placebo | DRUG | Inhaled Placebo, sterile saline |
Inclusion Criteria: * Males and females, 18 to 65 years of age * No clinically important abnormal physical findings at Screening * No clinically relevant abnormalities in the results of laboratory evaluation at Screening * Must test negative for hepatitis B virus (HBV), hepatitis C virus (HCV), and...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 9 | PHASE3 | VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA, VNZ/TEZ/D-IVA, VX-522 mRNA therapy |
| Sionna Therapeutics, Inc. | SION | 2 | PHASE2 | SION-719, SION-451, SION-2222, SION-109 |
| BiomX Ltd | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Illumina, Inc. | ILMN | 1 | — | Undisclosed |