Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers

Amendment history

1. Sep 9, 2026

   Minor

   3 amendments

   3 re-verifications since 2010-09-15, no change to tracked fields

   v11-v13

2. Jun 29, 2010

   Notable

   Primary endpoint revised

   Secondary endpoints: details revised at 3 of 12 entries

   Show what changed: Primary endpoints

   Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by No Clinically Significant Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table

   Study Status, Outcome Measures, Outcome Measures (Results) · v10

3. Apr 16, 2010

   Notable

   Results first posted: May 7, 2010

   Primary endpoints: 3 to 1; Interventions: ST-246 (Drug) to Placebo (Drug), ST-246 (Drug); Secondary endpoints: 2 to 12; and 3 more

   Show all 7 changes in this update

   • Notable Results first posted: May 7, 2010
   • Notable Primary endpoints: 3 to 1
     Show what changed

     Assess the safety and tolerabilityNumber of aStudy singleParticipants doseWho perTolerated day of ST-246 for(250, 21400 daysor of800mg) exposureas Determined by No Clinically Significant Changes in humansSafety through history, physical examination, EKG, and laboratory testsParameters
   • Minor Interventions: ST-246 (Drug) to Placebo (Drug), ST-246 (Drug)
   • Minor Secondary endpoints: 2 to 12
     Show what changed

     Assess the pharmacokineticsEvaluation of SIGA-246Pharmacokinetic inParameters healthyto volunteersAssess Interventions: Cmax for the rangeEvaluation of dosesPharmacokinetic administered.Parameters to Assess Interventions: Cmax Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax Evaluation of Pharmacokinetic Parameters to As [...]
   • Minor Study description expanded, about 12 words
     Show what changed

     This iswas a double-blind, placebo-controlled, dose-escalating, multiple-dose study of oralorally 250, 400 or 800mgadministered ST-246 into 30 healthy volunteers ages 18-50 years, randomized to receive either active drug (8 subjects) or placebo (2 subjects) in 1 of 3 dosing groups (8250, per400 or 800mg groups). Each dose group), whileof the10 6was remainingdivided volunteersinto two cohorts of 5 subjects (24 peractive doseand group) will receive1 placebo). The first 5cohort subjects of each group will bewas dosed approximately 14-8 weekweeks before the second 5 subjectscohort of each dose gro [...] [...]
   • Minor Study title revised
     Show what changed

     Phase I, Escalating, Multiple-Dose, Phase 1ST-246 Safety, Tolerability &and PKPharmacokinetics 21-Day Trial 21 Days in Healthy Volunteers
   • Minor Study arms: 0 to 2

   Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information · v9

4. May 14, 2009

   Minor

   Study Status

   Re-verified, no change to tracked fields

   v8

5. Mar 5, 2008

   Minor

   Trial status: Active, Not Recruiting to Completed

   Primary completion date: Feb 2008; Study completion date changed from estimate of Oct 2007 to Feb 2008

   Study Status · v7

11. Feb 5, 2007

    Minor

    Study First Submitted

• Stopped: an ongoing trial was terminated, suspended or withdrawn.
• Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
• Minor: routine progress and housekeeping, such as sites added or enrollment closed.