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VacciniaPhase 1NCT00303225

SIGA-246 to Treat Smallpox

A Phase 1 study testing Vaccine: SIGA-246 in people with Vaccinia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will test an experimental antiviral drug called SIGA-246 for use against the smallpox virus (variola). Although smallpox has been universally eradicated, it could possibly be brought back as a bioweapon. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Vaccinia
What is being tested?
Vaccine: SIGA-246
Type of treatment
Vaccines
How many people
0 participants
Where
1 siteUnited States
Study dates
13 Mar 2006to 4 Aug 2006
Phase
Phase 1
Are there results?
None posted in the registry

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

Who may be able to join

  • A participant must meet all of the following criteria:
  • 18 to 50 years old, inclusive.
  • Available for clinical follow-up for the duration of the study.
  • Able and willing to give written informed consent.
  • In good general health without clinically significant medical history.
  • Be able to refrain from taking any medications for 48 hours after study agent administration.
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  • Have adequate venous access.
  • Physical examination and laboratory results without clinically significant findings within the 28 days prior to receipt of study drug (i.e., satisfactorily completed screening).
  • Laboratory criteria within 28 days prior to receipt of study drug:
  • Hemoglobin within institutional normal range.
  • WBC within institutional normal range.
  • Absolute neutrophil count (ANC) within institutional normal range.
  • Total lymphocyte count within institutional normal range.
  • Platelets within institutional normal range.
  • ALT (SGPT) within institutional norm range. If the ALT is not within normal limits, it may be repeated once within the 28 days prior to receipt of the study drug.
  • Serum creatinine within institutional normal range.
  • Normal urinalysis defined as negative glucose, negative or trace protein, and negative or trace blood in the urine.
  • Negative beta-HCG pregnancy test (urine or serum) on day of receipt of study drug for women of childbearing potential.
  • The participant or his or her partner has undergone surgical sterlization, or the participant agrees either to be abstinent (i.e., heterosexually inactive) or to consistently use two of the following non-hormonal methods of contraception within the 21 days prior to receipt of the study drug and throughout the duration of the study:
  • Condoms, male or female, with or without a spermicide;
  • diaphragm or cervical cap with spermicide;
  • intrauterine device.

Who cannot join

  • A volunteer will be excluded if one or more of the following conditions apply:
  • Woman who is breast-feeding or planning to become pregnant prior to or during the 4 weeks of study participation.
  • Volunteer is on any concomitant medications, including over the counter medications or herbal supplements, for 14 days before the administration of the study agent.
  • Volunteer has a history of any clinically significant conditions including:
  • Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes.
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  • History of thyroidectomy or thyroid disease that required medication within the past 12 months.
  • Serious angioedema episodes within the previous three years or requiring medication in the previous two years.
  • Hypertension requiring medication.
  • Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
  • Malignancy that is active, or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.
  • Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.
  • Volunteer has:
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
  • Inability to swallow study medication.
  • Any clinically significant abnormal electrocardiogram findings as determined by the cardiologist in the context of the volunteer's history.
  • Received experimental drug within 30 days of study entry or will participate in any experimental study during the study period.
  • Active illicit drug or alcohol abuse.
  • Any clinically significant lactose intolerance that according to the clinician would be unacceptable for study participation, e.g. lactose intolerance that requires Lactaid or other OTC medications to prevent or alleviate symptoms.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institute of Allergy and Infectious Diseases (NIAID)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled, Ascending Single-Dose, Phase I Trial of the Anti-Orthopoxvirus Compound SIGA-246 in Healthy Volunteers

This study will test an experimental antiviral drug called SIGA-246 for use against the smallpox virus (variola). Although smallpox has been universally eradicated, it could possibly be brought back as a bioweapon. In the event of a smallpox attack, it would be best to have an antiviral medication in addition to the smallpox vaccine. SIGA-246 has shown to have activity against other viruses from the same family (orthopoxvirus) that smallpox belongs to.

Healthy volunteers who are 18-50 years of age and are not pregnant or breastfeeding may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, and an electrocardiogram.

Read more

Participants are randomly assigned to receive a one-time dose of SIGA-246 (either 500 mg, 1000 mg, or 2000 mg) or a placebo (sugar pill) taken by mouth. They report to the clinic in the morning for the following procedures:

  • Insertion of intravenous (IV) line in the forearm.
  • Blood and urine tests before taking the study drug.
  • Drug administration within 30 minutes of eating a light breakfast.
  • Blood sampling from the IV line at 30 minutes and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 5 and 6, 10 and 12 hours after taking SIGA-246 to determine how the drug is absorbed, distributed, broken down and excreted. Samples are also collected by needle stick at 24 and 48 hours for the same tests.
  • Electrocardiogram at 2 hours and 24 hours after taking SIGA-246.
  • 24-hour urine collection after taking the SIGA-246.
  • Complete diary card at home for 7 days after taking the SIGA-246.
  • Follow-up visits at about 2 weeks and about 4 weeks after taking SIGA-246.
  • Checks for health changes or problems at every visit.
Read the detailed description

Historically, smallpox has been responsible for hundreds of millions of deaths. In 1980 the World Health Organization declared the global eradication of smallpox which was achieved through a surveillance and vaccination program using live virus vaccine. In spite of its eradication, the deliberate use of smallpox as a bioterrorist agent remains a threat. While there is an effective vaccine, there have been concerns regarding vaccine complications which have prevented universal vaccination in the absence of disease exposure. In addition, in the event of a smallpox outbreak vaccination may be ineffective in immunocompromised individuals and in those who were exposed to the virus more than 3 days prior to vaccination. Antiviral therapy may be able to supplement a vaccine, however, there are limitations of the currently available drug options. SIGA-246 is an oral medication that has been shown to be highly active against variola virus and has demonstrated safety in animal models. The primary objective of this study is to assess the safety and tolerability of SIGA-246 at various doses with a secondary objective of evaluating the pharmacokinetics of the drug. To achieve these objectives, 30 healthy volunteers will be enrolled into one of three dosing groups (500 mg, 1000 mg, or 2000 mg) to receive an oral, single dose of SIGA-246 or placebo. In each of the three ascending dosing groups there will be 8 active drug recipients and 2 placebo recipients. Safety of the study agents will be assessed by history, physical, and laboratory evaluations. Pharmacokinetic endpoints include C(max), T(max), t(1/2), AUC, CI and urinary excretion. Urine will be collected in 3 8-hour intervals and serial blood samples will be obtained after study agent administration.

Conditions
Vaccinia
Being tested
Vaccine: SIGA-246
Keywords
Biodefense, Smallpox, Monkeypox, Vaccinia, Prophylaxis, Healthy Volunteer, HV
Medical subject headings
Vaccinia, Smallpox, Mpox, Monkeypox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaccine: SIGA-246Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2006 (estimated)
  2. Study start13 Mar 2006
  3. Study completion4 Aug 2006

Resources

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
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00303225
Sponsor's protocol ID
060114
Other IDs
06-I-0114
Status last verified
4 Aug 2006
First submitted
14 Mar 2006
Last updated
2 Jul 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vaccine: SIGA-246 in people with Vaccinia, run by National Institute of Allergy and Infectious Diseases (NIAID) 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?

The sponsor lists 22 inclusion and 19 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 2 Jul 2017. 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. 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?

The study was withdrawn before enrolling participants, so there are no results.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00303225.

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 2 Jul 2017.

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