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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07035990 | Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants. | PHASE1 | RECRUITING | 144 | — | — | Jul 23, 2025 | Jun 1, 2026 | Sep 3, 2025 | 2 | Australia |
Adverse reactions to the study drug combination SION-451 and SION-109 will be measured.
Adverse events to the study drug combination SION-451 and SION-2222 will be measured
| Arm | Type | Description |
|---|---|---|
| SION-451 + SION-2222 | EXPERIMENTAL | All participants who receive SION-451 in combination with SION-2222 |
| Placebo matched to SION-451 and SION-2222 | PLACEBO_COMPARATOR | - |
| SION 451 + SION 109 | EXPERIMENTAL | All participants who receive SION-451 in combination with SION-109 |
| Placebo matched to SION-451 and SION-109 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SION-451 | DRUG | * Pharmaceutical form: tablet * Route of administration: oral |
| SION-2222 | DRUG | * Pharmaceutical form: capsule * Route of administration: oral |
| SION-109 | DRUG | * Pharmaceutical form: tablet * Route of administration: oral |
| Placebo SION-451 | DRUG | Placebo matched to SION-451 |
| Placebo SION-2222 | DRUG | Placebo matched to SION-2222 |
| Placebo SION-109 | DRUG | Placebo matched to SION-109 |
Inclusion Criteria: 1. Healthy male or female adult participants aged 18 to 55 years, inclusive, at the time of consent. 2. Weight of at least 45 kg and body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening. 3. Participant is willing to abstain from alcohol, caffeine, smoking and nic...
| 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 |