HealthyPhase 1SIGA-246-002NCT00431951
Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
A Phase 1 study testing ST-246 in people with Healthy, run by SIGA Technologies at 1 site in United States.
Trial summary
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ST-246
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Feb 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Subject Inclusion Criteria:
- Healthy volunteers
- Ability to Consent
- Not taking any other medication
- Adequate venous access
- Using adequate birth control
Subject Exclusion Criteria:
- Inability to swallow study medication.
- Pregnant or breastfeeding
- Received experimental drug within 30 days of study entry or will participate in any experimental study during the study period.
- Current drug abuse, alcohol abuse, or homelessness.
- Taking concomitant medication
- Lactose Intolerance
- Medical condition; e.g., asthma, diabetes, thyroid disease, angioedema, BMI >35 or <18, hypertension, bleeding disorder, malignancy, seizure, neutropenia, Hepatitis B or C, HIV or AIDS.
- Any condition, occupational reason or other responsibility that, in the judgment of the Investigator, would jeopardize the safety or rights of a volunteer, or render the subject unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Escalating, Multiple-dose, Phase I Trial to Assess Safety, Tolerability and Pharmacokinetics of ST-246 Administered as a Single Daily Dose for 21 Days in Healthy, Non-fasted Volunteers
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.
Read the detailed description
This was a double-blind, placebo-controlled, dose-escalating, multiple-dose study of orally administered ST-246 to 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 (250, 400 or 800mg groups). Each dose group of 10 was divided into two cohorts of 5 subjects (4 active and 1 placebo). The first cohort was dosed approximately 4-8 weeks before the second cohort of each dose group. Dose groups completed the study treatment approximately 5 weeks prior to the start of the following dose group. Study procedures included several overnight stays, medical history/exam, laboratory testing done by blood draw, and electrocardiograms.
- Conditions
- Healthy
- Being tested
- ST-246, Placebo
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST-246Drug
Also called Tecovirimat
250 mg, 400 mg or 800 mg capsules given once daily for 21 days
PlaceboDrug
Also called Placebo to match ST-246
Capsules to match experimental drug
| Study group | Role | What they receive |
|---|---|---|
| ST-246 | Experimental | 250 mg, 400 mg or 800 mg of ST-246 given once daily for 21 days Receives: Drug: ST-246 |
| placebo | Placebo comparator | Placebo to match ST-246 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table
Evaluated safety parameters included:
- physical examination/vital signs
- electrocardiograms (heart rate, PR interval, QRS duration, QT interval, and QTc Bazett)
- laboratory safety tests (hematology, chemistry, urinalysis)
- 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.
Measured: Days 1, 6, 14-16, 21-24, 28-31, and 51-53
Secondary outcomes (12)
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data
Measured: Day 1
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data
Measured: Day 6
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
Cmax: Maximum drug concentration in plasma determined directly from individual concentration-time data
Measured: Day 21
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.
Measured: Day 1
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.
Measured: Day 6
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
Tmax: Time to reach maximum drug concentration in plasma calculated from [plasma] versus time profiles.
Measured: Day 21
Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½
t½: Observed terminal elimination half-life determined after the last dose on Day 21
Measured: Day 21
Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule
Measured: Day 1
Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule
Measured: Day 6
Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
AUCtau: Area under the plasma concentration-time curve for each dosing interval (from time 0 to 24 hours sample) determined using the linear trapezoidal rule
Measured: Day 21
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)
Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21
Measured: Day 1
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)
Ae(0-24): Cumulative amount of drug excreted unchanged in urine over 24 hours (three 8-hour collection periods), determined on Days 1 and 21
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIGA Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas C Marbury, MD, Principal investigator, Orlando Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431951
- Sponsor's protocol ID
- SIGA-246-002
- Other IDs
- HHSN266200600014C
- Acronym
- SIGA-246-002
- Status last verified
- Sep 2010
- First submitted
- 2 Feb 2007
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Escalating, Multiple-dose, Phase I Trial to Assess Safety, Tolerability and Pharmacokinetics of ST-246 Administered as a Single Daily Dose for 21 Days in Healthy, Non-fasted Volunteers
- ClinicalTrials.gov ID
- NCT00431951
- Acronym / sponsor ID
- SIGA-246-002 / SIGA-246-002
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SIGA TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Feb 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Feb 2007 (estimated)
- Results
- Posted 7 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.
Detailed description
This was a double-blind, placebo-controlled, dose-escalating, multiple-dose study of orally administered ST-246 to 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 (250, 400 or 800mg groups). Each dose group of 10 was divided into two cohorts of 5 subjects (4 active and 1 placebo). The first cohort was dosed approximately 4-8 weeks before the second cohort of each dose group. Dose groups completed the study treatment approximately 5 weeks prior to the start of the following dose group. Study procedures included several overnight stays, medical history/exam, laboratory testing done by blood draw, and electrocardiograms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ST-246 | Experimental | Drug: ST-246250 mg, 400 mg or 800 mg of ST-246 given once daily for 21 days |
| placebo | Placebo comparator | Drug: PlaceboPlacebo to match ST-246 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST-246Also: Tecovirimat250 mg, 400 mg or 800 mg capsules given once daily for 21 days | Drug | ST-246 |
| PlaceboAlso: Placebo to match ST-246Capsules to match experimental drug | Drug | placebo |
Primary outcome
Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table
Time frame: Days 1, 6, 14-16, 21-24, 28-31, and 51-53
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.
12 secondary outcomes
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
Time frame: Day 1
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
Time frame: Day 6
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Cmax
Time frame: Day 21
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
Time frame: Day 1
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
Time frame: Day 6
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Tmax
Time frame: Day 21
Evaluation of Pharmacokinetic Parameters to Assess Interventions: t½
Time frame: Day 21
Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
Time frame: Day 1
Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
Time frame: Day 6
Evaluation of Pharmacokinetic Parameters to Assess Interventions: AUCtau
Time frame: Day 21
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)
Time frame: Day 1
Evaluation of Pharmacokinetic Parameters to Assess Interventions: Ae(0-24)
Time frame: Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C Marbury, MD principal investigator
Orlando Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ST-246 in people with Healthy, run by SIGA Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Study Participants Who Tolerated ST-246 (250, 400 or 800mg) as Determined by Changes in Safety Parameters, According to the Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Events (AE) Grading Table (time frame: Days 1, 6, 14-16, 21-24, 28-31, and 51-53). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.