Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tecovirimat
ST-246 Days 1- 3 · 3 trials · 3 indications
To determine the safety and tolerability of oral tecovirimat
Number of participants with adverse events when TPOXX or TPOXX Placebo is coadministered with JYNNEOS
Least squared geometric mean
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 |
|---|---|---|
| Active | ACTIVE_COMPARATOR | 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects |
| Placebo | PLACEBO_COMPARATOR | matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects |
| JYNNEOS + TPOXX | ACTIVE_COMPARATOR | An oral dose of 600 mg (3 × 200 mg capsules) TPOXX BID (every 12 hours \[±30 minutes\]) for 28 days and a single AM SC dose of 0.5 mL JYNNEOS on Day 1 and Day 29. JYNNEOS will be administered with TPOXX concomitantly on Day 1 |
| JYNNEOS + matching TPOXX placebo | PLACEBO_COMPARATOR | An oral dose of placebo (3 capsules identical to TPOXX) BID (every 12 hours \[±30 minutes\]) for 28 days and a single AM SC dose of 0.5 mL JYNNEOS on Day 1 and Day 29. JYNNEOS will be administered with TPOXX placebo concomitantly on Day 1. |
| 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 |
|---|---|---|
| tecovirimat | DRUG | Study is based on Animal Regulatory Rule |
| Placebo | OTHER | Does not apply |
| Smallpox and Mpox Vaccine | DRUG | vaccine |
| 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: * 18 to 80 years old, inclusive * Available for clinical follow-up for the duration of the study * Able and willing to give informed consent * In good general health without clinically significant medical history; not have been hospitalized for a chronic medical condition for th...
ST-246 Days 1-3 is an investigational small molecule antiviral being developed by SIGA Technologies Inc. for orthopoxviral disease, a category that includes smallpox and monkeypox. It is a Phase 1 candidate that has been studied in a single completed clinical trial. It is not an approved product.
ST-246 Days 1-3 is being developed for orthopoxviral disease, including smallpox and monkeypox. The completed Phase 1 study enrolled healthy adult volunteers rather than patients with active infection, so the program remains at an early stage of clinical development for these indications.
ST-246 Days 1-3 is developed by SIGA Technologies Inc., which trades on the Nasdaq under the ticker SIGA. The company is the sponsor of the Phase 1 study of the candidate in orthopoxviral disease.
ST-246 Days 1-3 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program has not reached later-stage testing, and the drug is investigational rather than approved for any indication.
ST-246 Days 1-3 has been studied in one completed Phase 1 trial, NCT00728689, titled Phase I Trial of an Investigational Small Pox Medication. It enrolled 12 healthy adult volunteers in the United States, was randomized, double blind, and used an active control.
Yes. ST-246 Days 1-3 and ST-246 Days 1 - 3 refer to the same SIGA Technologies candidate for orthopoxviral disease. The two spellings differ only in spacing around the dash, so searches using either form point to the same Phase 1 program.