Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ST-246 Days 1- 3 · 1 trial · 3 indications
Mean terminal half-life (t½; hrs) for Forms I and V were calculated from \[plasma\] vs time profiles.
Area under the drug concentration-time curve from time zero to time t, where t is the last timepoint with a drug concentration ≥ lowest obtainable quantification (AUC0-τ; ng\*hr/mL).
Area under the drug concentration-time curve from time zero to infinity (AUC0-∞; ng\*hr/mL).
Maximum drug concentration in plasma, determined directly from individual concentration-time data (Cmax)
Time to maximum plasma concentration(Tmax; hrs) for Forms I and V were calculated from \[plasma\] vs time profiles.
| Arm | Type | Description |
|---|---|---|
| Group ST-246 Form I (followed by Form V) | ACTIVE_COMPARATOR | Each of six subjects receive a single oral 400 mg dose (2×200 mg) of ST-246 Form I (monohydrate) in the first intervention period, followed 10 days later (3 days post-treatment monitoring and 7 days wash-out period) in the second intervention period by a single oral 400 mg dose (2×200 mg) of ST-246 Form V (hemihydrate). Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat. |
| Group ST-246 Form V (followed by Form I) | ACTIVE_COMPARATOR | Each of six subjects receive a single oral 400 mg dose (2×200 mg) of ST-246 Form V (hemihydrate) in the first intervention period, followed 10 days later (3 days post-treatment monitoring and 7 days wash-out period) in the second intervention period by a single oral 400 mg dose (2×200 mg) of ST-246 Form I (monohydrate). Both forms of drug are orally administered within 30 minutes after a standard light meal consisting of 400-450 calories and approximately 25% fat. |
| Name | Type | Description |
|---|---|---|
| ST-246 Days 1 - 3 | DRUG | First Intervention is on Days 1 - 3, and includes 6 patients dosed once orally with ST-246 Form I (Arm 1), and 6 patients dosed once orally with ST-246 Form V (Arm 2). |
| ST-246 Days 11 - 13 | DRUG | Second Intervention is on Days 11 - 13 (after a 3 day post-treatment monitoring and 7 day wash-out period) where the 6 patients previously given ST-246 Form I (Arm 1) are now dosed once orally with ST-246 Form V, and the 6 patients previously given ST-246 Form V (Arm 2) are now dosed once orally with ST-246 Form I. |
Inclusion Criteria: 1. 18 to 50 years 2. Available for clinical follow-up duration of study. 3. Able/willing to give written consent. 4. Good general health; no clinically significant medical history. 5. Refrain from taking any medications from screening through 72 hours after last dose. 6. Adequat...
ST-246 Days 1-3 is an investigational small molecule being developed for the treatment of Orthopoxviral Disease, which includes smallpox and monkeypox. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
ST-246 Days 1-3 is being developed by SIGA Technologies Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SIGA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
ST-246 Days 1-3 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The Phase 1 trial has been completed, and the drug remains under investigation for Orthopoxviral Disease.
ST-246 Days 1-3 has been studied in one completed Phase 1 clinical trial, identified as NCT00728689. This trial was a randomized, double-blind, active-controlled study involving 12 healthy adult volunteers in the United States, evaluating the drug for Orthopoxviral Disease, smallpox, and monkeypox.
ST-246 Days 1-3 is a small molecule antiviral drug. It is designed to target and inhibit a protein involved in the replication of orthopoxviruses, which are the viruses that cause smallpox and monkeypox. By blocking this protein, the drug aims to prevent the virus from spreading within the body.