Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ST-246 · 2 trials · 2 indications
Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.
Evaluated safety parameters included: 1. physical examination/vital signs 2. electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett) 3. laboratory safety tests (hematology, chemistry, urinalysis) 4. adverse events (AEs) For a)-c), statistical values (mean, standard deviation, median, minimum, maximum) and changes from baseline (Day 1 pre-dose) to each time-point, were compared to laboratory normal reference ranges. If values for a)-d) were a Grade 3 or higher (in DAIDS AE Table)and ST-246-related, they were considered severe and significant, respectively.
| Arm | Type | Description |
|---|---|---|
| ST-246 400 mg | EXPERIMENTAL | ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days |
| ST-246 600 mg | EXPERIMENTAL | ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo capsules, Orally Once Daily for 14 days |
| ST-246 | EXPERIMENTAL | 250 mg, 400 mg or 800 mg of ST-246 given once daily for 21 days |
| Name | Type | Description |
|---|---|---|
| ST-246 400 mg | DRUG | Capsules, 400 mg daily for 14 days |
| ST-246 600 mg | DRUG | Capsules, 600 mg daily for 14 days |
| Placebo | DRUG | Capsules, once daily for 14 days |
| ST-246 | DRUG | 250 mg, 400 mg or 800 mg capsules given once daily for 21 days |
Inclusion Criteria: 1. 18 - 75 yrs 2. Healthy volunteer 3. Ability to consent 4. Available for clinical follow-up for study 5. Not taking other medications 6. Adequate venous access 7. Using adequate birth control; negative pregnancy test 8. Able and willing to avoid alcohol for screening and study...
ST-246 is an investigational small molecule being developed for Orthopoxviral Disease and for use in healthy volunteers. It is being studied as a potential treatment for orthopoxviral infections, which include diseases such as smallpox and monkeypox. The drug is currently in clinical development and is not yet approved.
ST-246 is being developed by SIGA Technologies Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SIGA. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of ST-246 in healthy volunteers and in patients with Orthopoxviral Disease.
ST-246 is in clinical development, with completed trials in Phase 1 and Phase 2. The Phase 1 trial evaluated safety, tolerability, and pharmacokinetics over 21 days in healthy volunteers, while the Phase 2 trial assessed safety, tolerability, and pharmacokinetics in healthy volunteers for Orthopoxviral Disease. ST-246 is investigational and not yet approved.
ST-246 has been studied in two completed clinical trials. NCT00431951 was a Phase 1, escalating, multiple-dose trial in healthy volunteers. NCT00907803 was a Phase 2 trial evaluating the safety, tolerability, and pharmacokinetics of the anti-orthopox drug ST-246. Both trials were conducted in the United States.
ST-246 is not FDA approved. It is an investigational drug currently in clinical development. Clinical trials have been completed to evaluate its safety and tolerability, but it has not yet received approval from the FDA for any indication. The drug remains under investigation for Orthopoxviral Disease.