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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07503405 | Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model | PHASE2 | NOT YET_RECRUITING | 165 | — | — | Jun 1, 2026 | Apr 1, 2027 | Mar 31, 2026 | 1 | United Kingdom |
| NCT07371650 | This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Tivoxavir Marboxil in Patients With Mild to Moderate Influenza | PHASE2 | ACTIVE NOT_RECRUITING | 105 | — | — | Dec 15, 2025 | Jan 1, 2027 | Mar 27, 2026 | 1 | Australia |
Defined as at least 2 quantifiable (≥LLOQ) qRT-PCR samples reported over 4 planned consecutive assessments within 48 hours.
At least one incidence of a symptom from the symptom diary card of grade ≥2.
Number of participants with Adverse Events (AEs), serious Adverse Events (SAEs) (including withdrawals due to AEs)
Number of participants with abnormal laboratory tests results
| Arm | Type | Description |
|---|---|---|
| TRX-100 Timing 1 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 2 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 3 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| TRX-100 Timing 4 | EXPERIMENTAL | Participants in this arm will receive single oral dose of the investigational drug, TRX-100. |
| Placebo Timing 1 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 2 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 3 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| Placebo Timing 4 | PLACEBO_COMPARATOR | Participants in this arm will receive single oral dose of the Placebo. |
| TRX-100 Dose Level 1 | EXPERIMENTAL | Participants in this arm will receive a lower single oral dose of the investigational drug, TRX-100. |
| TRX-100 Dose Level 2 | EXPERIMENTAL | Participants in this arm will receive a higher single oral dose of the investigational drug, TRX-100. |
| Standard of Care (SOC) | ACTIVE_COMPARATOR | Participants in this arm will not receive the investigational drug. Instead, they will receive the current standard of care treatment. This arm serves as a comparator to evaluate the effects of the investigational drug. |
| Name | Type | Description |
|---|---|---|
| TRX-100 | DRUG | A single oral dose in capsules |
| Placebo | DRUG | A single oral dose in capsules |
| Influenza A/France/759/2021 (H1N1) virus | BIOLOGICAL | A single dose of challenge agent will be delivered Intranasal |
| Standard of Care (SOC) | DRUG | Standard of Care Influenza Antiviral therapy |
Inclusion Criteria: 1. Written informed consent signed and dated by the participant and the PI/investigator obtained before any assessment is performed. 2. Aged between 18 and 55 years old on the day prior to signing the consent form, inclusive. 3. A total body weight ≥50 kg and body mass index (BM...