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CompletedNCT04392739Updated Sep 11, 2026Results posted

Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG

A Phase 4 interventional study of Tpoxx in Smallpox, sponsored by SIGA Technologies. Completed at 1 site in United States. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by SIGA Technologies · Phase 4, Interventional, and Other

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jul 2019, registered May 2020).
Phase
Phase 4
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
20 Years to 50 Years
Sex
All
01

Study summary

Safety and PK study in adults weighing more than 120 kg

Read the detailed description

The primary objective of this study is to determine the pharmacokinetic (PK) profile of 600 mg oral TPOXX (3 × 200-mg capsules) administered twice daily (BID) for 7 days in adult subjects weighing more than 120 kg to determine if a change in dosing regimen would be needed in these patients.

Secondary:

The secondary objective of this study is to evaluate the safety and tolerability of 600 mg oral TPOXX administered BID for 7 days in healthy adult subjects weighing more than 120 kg.

02

Conditions studied

  • Smallpox

Browse trials for

03

In context

Smallpox

73 studies on the registry are indexed under Smallpox; 5 are open to participants now.

This study's enrollment of 34 is below the median of 150 across 61 interventional studies indexed under Smallpox.

Browse Smallpox studies →

Lead sponsor

SIGA Technologies is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject is male or female between 18 and 50 years of age, inclusive.
  2. Subject has a body weight >120 kg at screening, at check-in on Day -1, and prior to dosing on Day 1.

  3. Women of , have a negative β human chorionic gonadotropin pregnancy test (serum) at the screening visit and a confirmatory negative serum pregnancy test on Day -1 before receipt of study drug, and meet 1 of the following criteria:

    1. The subject or their partner has undergone surgical sterilization
    2. The subject is , defined as 12 consecutive months with no menses without an alternative medical cause and has a documented plasma follicle-stimulating hormone level >40 IU/mL
    3. The subject agrees to be abstinent (ie, heterosexually inactive or women in a religious order)
    4. The subject agrees to consistently use 1 of the following methods of from the beginning of screening (which they had been consistently using for at least 30 days before the first dose of study drug) through 30 days after the last dose of study drug:

    i. Condoms, male or female, with a spermicide NOTE: For male subjects, condoms must be used for 90 days after the last dose of study drug.

    ii. Diaphragm or cervical cap with spermicide

    iii. Intrauterine device with spermicide

    iv. Oral contraceptives or other hormonal methods NOTE: Subject must agree to use an additional nonhormonal method of contraception in conjunction with oral contraceptives.

    v. Male sexual partner who had undergone a vasectomy at least 3 months before screening

  4. Male subjects must agree to not donate sperm from the first dose of study drug through 90 days after the last dose of study drug.
  5. Subject is considered by the investigator to be in good general health as determined by medical history (no hospitalizations for chronic medical conditions in the previous 2 years), clinical laboratory results, vital sign measurements, 12-lead (ECG) results, and physical examination findings at screening.
  6. Subject agrees to comply with all protocol requirements.
  7. Subject is able to provide written .
  8. Subject agrees to comply with the dietary requirements.
  9. Subject does not intend to lose

Exclusion criteria

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

  1. Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the last dose of study drug.

  2. Subject has a history of any conditions including:

    • Asthma treated with oral systemic within the past 6 months
    • Diabetes mellitus (type 1 or 2), with the exception of gestational diabetes
    • Thyroidectomy or thyroid disease that required medication within the past 12 months
    • Serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 years
    • Head trauma resulting in a diagnosis of traumatic brain injury other than concussion
    • Frequent episodes of headache.
  3. Subject has received treatment in another clinical study of an drug (or medical device) within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug.
  4. Subject has been previously enrolled in any clinical study involving TPOXX (tecovirimat).
  5. Subject has a history of relevant drug and/or food allergies (ie, allergy to tecovirimat or , or any significant food allergy that could preclude a standard diet in the study site).
  6. Subject has any condition possibly affecting drug absorption (eg, previous surgery on the gastrointestinal tract, including removal of parts of the stomach, bowel, liver, gallbladder, or pancreas, with the exception of appendectomy).

  7. Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of the first dose of study drug), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild joint disease unassociated with collagen vascular disease) may be made following discussions with the medical monitor.

    Page 10

  8. Subject has a history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or risk factors for torsades de pointes (eg, heart failure, hypokalemia).
  9. Subject has a family history of sudden cardiac death, not clearly due to acute myocardial infarction.
  10. Subject has a seizure disorder or history of seizures (does not include childhood febrile seizures) or a past history that increases seizure risks such as significant head injury that caused loss of consciousness or other changes in the subject's daily function, concussion, stroke, central nervous system infection or disease, or alcohol or drug abuse or family history of idiopathic seizures.
  11. Subject has a history of a peptic ulcer or significant gastrointestinal bleed.
  12. Subject has a bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
  13. Subject has a 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 (subject should be in complete remission for at least 5 years).
  14. Subject has neutropenia or other blood dyscrasia determined to be clinically significant by the investigator.
  15. Subject has used any of the following prohibited medications from within 7 days (or 5 half-lives, whichever is longer) before the first dose of study drug: antidiabetic medication; anticoagulants; anticonvulsants; substrates of the breast cancer resistance protein transporter including methotrexate, mitoxantrone, imatinib, irinotecan, lapatinib, rosuvastatin, sulfasalazine, and topotecan; substrates of CYP2C8 including repaglinide, paclitaxel, Montelukast, pioglitazone, rosiglitazone; and substrates of CYP2C19 including S-mephenytoin, clobazam, diazepam, rabeprazole, voriconazole, lansoprazole, and omeprazole. Medications not listed here that are known (or thought) to be substrates may be allowed at the investigator's discretion, after consultation with the medical monitor, if administration poses little to no risk to the subject.
  16. Subject has a history of drug or alcohol abuse or dependency within the last year before screening.
  17. Subject has a history of an eating disorder.
  18. Subject has a current or recent (\<30 days before screening) history of clinically significant bacterial, fungal, or mycobacterial infection.
  19. Subject has a current clinically significant viral infection.
  20. Subject has a known clinically significant chronic viral infection (eg, human T cell lymphotropic virus I or II).
  21. Subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products within 48 hours before the first dose of study drug or throughout the study.
  22. Subject has used any prescription (excluding hormonal ) or over-the-counter medication (including herbal or nutritional supplements) within 14 days before the first dose of study drug.
  23. Subject demonstrates long-term use (≥14 consecutive days) of glucocorticoids including oral or parenteral prednisone or equivalent (>20 mg total dose per day) or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 1 month (low-dose [≤800 mcg/day of beclomethasone dipropionate or equivalent] inhaled and topical steroids are allowed).
  24. Subject has donated >450 mL blood or blood components within 30 days before the first dose of study drug. The investigator should instruct subjects who participate in this study to not donate blood or blood components for 4 weeks after the completion of the study.
  25. Subject is a smoker or has used nicotine or nicotine-containing products (eg, cigarettes, electronic vapor cigarettes, cigars, chewing tobacco, snuff, nicotine patches, or nicotine gum) within 6 months before the first dose of study drug.
  26. Subject has consumed pomegranate or pomegranate juice, pomelo fruits or pomelo juice, or alcohol within 72 hours before the first dose of study drug.
  27. Subject reports participation in strenuous activity or contact sports within 24 hours before the first dose of study drug.
  28. Subject has known or C infection or positive test for hepatitis B surface antigen, virus antibody, or type 1 or 2 antibodies at screening.
  29. Subject has a positive test result for amphetamines (including methamphetamines and ecstasy/methylenedioxymethamphetamine), barbiturates, benzodiazepines, cannabinoids (including tetrahydrocannabinol), cocaine metabolites, opiates (including heroin, codeine, and oxycodone), or alcohol at screening or check-in.

  30. Subject has any of the following laboratory test results within 28 days before the first dose of study drug:

    • Estimated serum (Cockcroft-Gault) \<90 mL/min
    • Creatinine in males >1.7 mg/dL and in females >1.4 mg/dL (1.3 times the upper central laboratory reference range)
    • ≤10% of the lower central laboratory reference range
    • White blood cell count not within the central laboratory reference range
    • \<1000 cells/mm3
    • Platelets not within ±10% of central laboratory reference range
    • >1.5 times above the upper central laboratory reference range
    • Aspartate aminotransferase >1.5 times above the upper central laboratory reference range
    • Alkaline phosphatase >20% above the upper central laboratory reference range
    • ≥7.0%
    • Cholesterol ≥300 mg/dL and low-density lipoprotein ≥190 mg/dL.
  31. Subject has a blood pressure considered to be clinically significant by the investigator. Blood pressure may be retested twice in the sitting position at 5-minute intervals.
  32. Subject has a resting heart rate of \<40 beats per minute or >100 beats per minute at screening.
  33. Subject has an abnormal at screening that is determined by the investigator to be clinically significant.
  34. Male subject has a >450 ms or female subject has a QTcF >470 ms at screening or Day -1.
  35. In the opinion of the investigator, the subject is not suitable for entry into the study.
Terms in these criteria, in plain language(21)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Other
    TPOXX

    TPOXX 600 mg BID x 7 days

    Drug: Tpoxx

Interventions

06

What researchers measure

Primary outcomes

  1. AUC0-t

    Area under the plasma concentration vs. time curve (AUC) from time 0 to the last quantifiable measurement following Day 7 dose administration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).

    Time frame: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).

  2. AUC0-24

    Area under the plasma concentration vs. time curve (AUC) from time 0 to the 24-hour time-point following Day 7 dose administration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7).

    Time frame: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7)

  3. AUC0-inf

    AUC from time 0 extrapolated to infinity

    Time frame: Day 7

  4. Cmax

    Maximum observed plasma drug concentration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7). The median time to achieve Cmax was 4 hours post-dose.

    Time frame: Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).

  5. Tmax

    Time to reach Cmax

    Time frame: Day 7

  6. t1/2

    Terminal elimination half-life

    Time frame: Day 7

  7. CL/F

    Apparent total body clearance

    Time frame: Day 7

  8. Vd/F

    Apparent volume of distribution

    Time frame: Day 7

  9. Ctrough

    Concentration observed prior to the next dose administration

    Time frame: Day 7

Secondary outcomes

  1. AEs as Assessed by CTCAE

    Number of subjects with AEs as assessed by CTCAE

    Time frame: 30 days

  2. Subjects With at Least 1 AEs

    Number of subjects reported at least 1 adverse event

    Time frame: 30 days

  3. Average Hemoglobin Concentration at Various Time Points; Mean (Standard Deviation)

    Table 14.3.2.1.1Summary of Actual Value and Change from Baseline in Hematology Safety Population Summary tables of observed values and changes from baseline: for hematology laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline visit.. Central laboratory reference ranges used for all clinical laboratory safety parameters

    Time frame: Baseline prior to dosing, 3 days post dose, 7 days post dose and 8 days post dose

  4. Average Serum Chemistry at Various Time Points; Mean (Standard Deviation)

    Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline. Central laboratory reference ranges used for all clinical laboratory safety parameters

    Time frame: Average Serum Chemistry at Baseline, 3 days post dose, 7 days post dose, and 8 days post dose

  5. Average Urinalysis pH Values at Various Time Points:Day 9; Mean (Standard Deviation)

    Table 14.3.2.3.2 Laboratory Results - Urinalysis Safety Population Urinalysis laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline visit. Central laboratory reference ranges used for all clinical laboratory safety parameters.

    Time frame: 8 days post dose

  6. Average Systolic and Diastolic Blood Pressures at 9 Day Time Point; Mean (Standard Deviation)

    Table 14.3.3.1.1 Vital Sign Results Safety Population Data listed shows the mean and standard deviation of systolic and diastolic blood pressure of 34 participants on day 9.

    Time frame: 9 days

  7. Average Heart Rate at 9 Day Time Point; Mean (Standard Deviation)

    Table 14.3.3.1.1 Vital Sign Results Safety Population Data listed shows the mean and standard deviation of heart rate of 34 participants on day 9.

    Time frame: 9 days

  8. Average Respiratory Rate at 9 Day Time Point; Mean (Standard Deviation)

    Table 14.3.3.1.1 Vital Sign Results Safety Population Data listed shows the mean and standard deviation of respiratory rates for 34 participants on day 9.

    Time frame: 9 days

  9. Average Body Temperature at 9 Day Time Point; Mean (Standard Deviation)

    Table 14.3.3.1.1 Vital Sign Results Safety Population Data listed shows the mean and standard deviation of body temperatures for 34 participants on day 9.

    Time frame: 9 days

  10. Average 12-lead ECG at 9 Day Time Point; Mean (Standard Deviation)

    Table 14.3.4.1.1 Electrocardiogram Results Safety Population Data listed shows the mean and standard deviation of 12 Lead EKG results for 34 participants on day 9.

    Time frame: 9 days

  11. Physical Examination at Baseline Compared to Physical Examination 9 Days Post Dose

    Listing 16.2.8.8 Physical Exam Safety Population Subjects were collated based on review of system and classified by assessment as "normal", "abnormal" or "assessments not done" on day 9.

    Time frame: 9 days

  12. Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Various Time Points Mean (Standard Deviation)

    Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline. Central laboratory reference ranges used for all clinical laboratory safety parameters

    Time frame: Day 1 pre dose, 3 days, 7 days, and 8 days post dose

  13. Albumin, Globulin, and Protein at Various Time Points Mean (Standard Deviation)

    Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline. Central laboratory reference ranges used for all clinical laboratory safety parameters

    Time frame: Day 1 pre dose, 3 days post dose, 7 days post dose and 8 days post dose

  14. Average Serum Chemistry at Various Time Points; Mean (Standard Deviation)

    Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline. Central laboratory reference ranges used for all clinical laboratory safety parameters

    Time frame: Day 1 pre dose, 3, 7, and 8 days post dose

  15. Urobilinogen (Umol/dl) 8 Days Post Dose (Day 9); Mean (Standard Deviation)

    Table 14.3.2.3.2 Laboratory Results - Urinalysis Safety Population Summary tables of observed values and changes from baseline: for urinalysis laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline visit. Central laboratory reference ranges used for all clinical laboratory safety parameters.

    Time frame: 8 days post dose

  16. 12-lead ECG Heart Rate at 9 Day Time Point; Mean (Standard Deviation)

    Table 14.3.4.1.1 Electrocardiogram Results Safety Population Data listed shows the mean and standard deviation of 12 Lead EKG heart rate for 34 participants on day 9.

    Time frame: 9 days

07

Results

Posted Sep 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneTPOXX
Started34
Completed34
Not completed0

Outcome measures

PrimaryAUC0-t

Area under the plasma concentration vs. time curve (AUC) from time 0 to the last quantifiable measurement following Day 7 dose administration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).

Time frame:
Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).
Reported as:
Mean · ng*h/mL
AUC0-t
ng*h/mLTPOXX
AUC0-t29500 ± 26.0
PrimaryAUC0-24

Area under the plasma concentration vs. time curve (AUC) from time 0 to the 24-hour time-point following Day 7 dose administration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7).

Time frame:
Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7)
Reported as:
Mean · ng*h/mL
AUC0-24
ng*h/mLTPOXX
AUC0-2420000 ± 23.0
PrimaryAUC0-inf

AUC from time 0 extrapolated to infinity

Time frame:
Day 7
Reported as:
Mean · ng*h/mL
AUC0-inf
ng*h/mLTPOXX
AUC0-inf33200 ± 27.8
PrimaryCmax

Maximum observed plasma drug concentration. Samples were collected before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7). The median time to achieve Cmax was 4 hours post-dose.

Time frame:
Before the AM dose (0 hour), at 0.5, 1, 2, 4, 6, 8, 12 (before the PM dose), 14, 16, 18, 20, and 24 hours (Day 8, 24 hours after the AM dose on Day 7), and on Day 9 (48 hours after the AM dose on Day 7).
Reported as:
Mean · ng/mL
Cmax
ng/mLTPOXX
Cmax1350 ± 29.0
PrimaryTmax

Time to reach Cmax

Time frame:
Day 7
Reported as:
Median · h
Tmax
hTPOXX
Tmax4.00 (2.00 to 11.95)
Primaryt1/2

Terminal elimination half-life

Time frame:
Day 7
Reported as:
Mean · h
t1/2
hTPOXX
t1/212.9 ± 19.3
PrimaryCL/F

Apparent total body clearance

Time frame:
Day 7
Reported as:
Mean · L/h
CL/F
L/hTPOXX
CL/F64.8 ± 26.0
PrimaryVd/F

Apparent volume of distribution

Time frame:
Day 7
Reported as:
Mean · L
Vd/F
LTPOXX
Vd/F1180 ± 29.9
PrimaryCtrough

Concentration observed prior to the next dose administration

Time frame:
Day 7
Reported as:
Mean · ng/mL
Ctrough
ng/mLTPOXX
Ctrough617 ± 35.6
SecondaryAEs as Assessed by CTCAE

Number of subjects with AEs as assessed by CTCAE

Time frame:
30 days
Reported as:
Number · participants
AEs as Assessed by CTCAE
participantsTPOXX
AEs as Assessed by CTCAE12
SecondarySubjects With at Least 1 AEs

Number of subjects reported at least 1 adverse event

Time frame:
30 days
Reported as:
Number · participants
Subjects With at Least 1 AEs
participantsTPOXX
Subjects With at Least 1 AEs9
SecondaryAverage Hemoglobin Concentration at Various Time Points; Mean (Standard Deviation)

Table 14.3.2.1.1Summary of Actual Value and Change from Baseline in Hematology Safety Population Summary tables of observed values and changes from baseline: for hematology laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline visit.. Central laboratory reference ranges used for all clinical laboratory safety parameters

Time frame:
Baseline prior to dosing, 3 days post dose, 7 days post dose and 8 days post dose
Reported as:
Mean · Hemoglobin (g/L)
Average Hemoglobin Concentration at Various Time Points; Mean (Standard Deviation)
Hemoglobin (g/L)TPOXX
Baseline138.0 ± 12.45
3 days post dose (Day 4)142.6 ± 14.43
7 days post dose (Day 8)142.0 ± 13.40
8 days post dose (Day 9)140.6 ± 13.35
SecondaryAverage Serum Chemistry at Various Time Points; Mean (Standard Deviation)

Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline. Central laboratory reference ranges used for all clinical laboratory safety parameters

Time frame:
Average Serum Chemistry at Baseline, 3 days post dose, 7 days post dose, and 8 days post dose
Reported as:
Mean · umol/L
Average Serum Chemistry at Various Time Points; Mean (Standard Deviation)
umol/LTPOXX
Bilirubin (umol/L) Baseline7.96 ± 3.339
Bilirubin (umol/L) 3 days post dose (Day 4)10.24 ± 3.760
Bilirubin (umol/L) 7 days post dose (Day 8)10.25 ± 3.393
Urate (umol/L) 3 days post dose (Day 4)406.0 ± 66.99
Urate (umol/L) 7 days post dose (Day 8)391.2 ± 65.17
Urate (umol/L) 8 days post dose (Day 9)391.5 ± 62.74
SecondaryAverage Urinalysis pH Values at Various Time Points:Day 9; Mean (Standard Deviation)

Table 14.3.2.3.2 Laboratory Results - Urinalysis Safety Population Urinalysis laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline visit. Central laboratory reference ranges used for all clinical laboratory safety parameters.

Time frame:
8 days post dose
Reported as:
Mean · pH
Average Urinalysis pH Values at Various Time Points:Day 9; Mean (Standard Deviation)
pHTPOXX
Average Urinalysis pH Values at Various Time Points:Day 9; Mean (Standard Deviation)5.93 ± 0.566
SecondaryAverage Systolic and Diastolic Blood Pressures at 9 Day Time Point; Mean (Standard Deviation)

Table 14.3.3.1.1 Vital Sign Results Safety Population Data listed shows the mean and standard deviation of systolic and diastolic blood pressure of 34 participants on day 9.

Time frame:
9 days
Reported as:
Mean · mmHg
Average Systolic and Diastolic Blood Pressures at 9 Day Time Point; Mean (Standard Deviation)
mmHgTPOXX
Systolic Blood Pressure (mmHg) 8 days post dose (Day 9)122.9 ± 11.41
Diastolic Blood Pressure (mmHg) 8 days post dose (Day 9)67.1 ± 8.91
SecondaryAverage Heart Rate at 9 Day Time Point; Mean (Standard Deviation)

Table 14.3.3.1.1 Vital Sign Results Safety Population Data listed shows the mean and standard deviation of heart rate of 34 participants on day 9.

Time frame:
9 days
Reported as:
Mean · beats per minute
Average Heart Rate at 9 Day Time Point; Mean (Standard Deviation)
beats per minuteTPOXX
Average Heart Rate at 9 Day Time Point; Mean (Standard Deviation)77.0 ± 9.96
SecondaryAverage Respiratory Rate at 9 Day Time Point; Mean (Standard Deviation)

Table 14.3.3.1.1 Vital Sign Results Safety Population Data listed shows the mean and standard deviation of respiratory rates for 34 participants on day 9.

Time frame:
9 days
Reported as:
Mean · breaths per minute
Average Respiratory Rate at 9 Day Time Point; Mean (Standard Deviation)
breaths per minuteTPOXX
Average Respiratory Rate at 9 Day Time Point; Mean (Standard Deviation)14.8 ± 2.15
SecondaryAverage Body Temperature at 9 Day Time Point; Mean (Standard Deviation)

Table 14.3.3.1.1 Vital Sign Results Safety Population Data listed shows the mean and standard deviation of body temperatures for 34 participants on day 9.

Time frame:
9 days
Reported as:
Mean · Celsius
Average Body Temperature at 9 Day Time Point; Mean (Standard Deviation)
CelsiusTPOXX
Average Body Temperature at 9 Day Time Point; Mean (Standard Deviation)36.50 ± 0.281
SecondaryAverage 12-lead ECG at 9 Day Time Point; Mean (Standard Deviation)

Table 14.3.4.1.1 Electrocardiogram Results Safety Population Data listed shows the mean and standard deviation of 12 Lead EKG results for 34 participants on day 9.

Time frame:
9 days
Reported as:
Mean · msec
Average 12-lead ECG at 9 Day Time Point; Mean (Standard Deviation)
msecTPOXX
PR Interval, Aggregate (msec) 8 days post dose (Day 9)171.1 ± 20.43
QRS Duration, Aggregate (msec) 8 days post dose (Day 9)95.9 ± 10.38
SecondaryPhysical Examination at Baseline Compared to Physical Examination 9 Days Post Dose

Listing 16.2.8.8 Physical Exam Safety Population Subjects were collated based on review of system and classified by assessment as "normal", "abnormal" or "assessments not done" on day 9.

Time frame:
9 days
Reported as:
Count of participants · Participants
Physical Examination at Baseline Compared to Physical Examination 9 Days Post Dose
ParticipantsTPOXX
8 days post dose (Day 9) Normal: Skin33
8 days post dose (Day 9) Abnormal: Skin1
8 days post dose (Day 9) Not Done: Skin0
8 days post dose (Day 9) Normal: HEENT34
8 days post dose (Day 9) Abnormal: HEENT0
8 days post dose (Day 9) HEENT: Not Done0
8 days post dose (Day 9) Normal: Pulmonary34
8 days post dose (Day 9) Abnormal: Pulmonary0
8 days post dose (Day 9) Not Done: Pulmonary0
8 days post dose (Day 9) Normal: Cardiovascular34
8 days post dose (Day 9) Abnormal: Cardiovascular0
8 days post dose (Day 9) Not done: Cardiovascular0
8 days post dose (Day 9) Abdomen: Normal34
8 days post dose (Day 9) Abnormal: Abdomen0
8 days post dose (Day 9) Not Done: Abdomen0
8 days post dose (Day 9) Normal: Lymph Nodes34
8 days post dose (Day 9) Abnormal: Lymph Nodes0
8 days post dose (Day 9) Not Done: Lymph Nodes0
8 days post dose (Day 9) Normal: Musculoskeletal33
8 days post dose (Day 9) Abnormal: Musculoskeletal1
8 days post dose (Day 9) Not Done: Musculoskeletal0
8 days post dose (Day 9) Normal: Neurological System34
8 days post dose (Day 9) Abnormal: Neurological System0
8 days post dose (Day 9) Not Done: Neurological System0
8 days post dose (Day 9) Normal: Other0
8 days post dose (Day 9) Abnormal: Other0
8 days post dose (Day 9) Not Done: Other34
SecondaryAlanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Various Time Points Mean (Standard Deviation)

Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline. Central laboratory reference ranges used for all clinical laboratory safety parameters

Time frame:
Day 1 pre dose, 3 days, 7 days, and 8 days post dose
Reported as:
Mean · IU/L
Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Various Time Points Mean (Standard Deviation)
IU/LTPOXX
Alanine Aminotransferase (IU/L) Baseline21.8 ± 8.87
Alanine Aminotransferase (IU/L) 3 days post dose (Day 4)23.5 ± 11.84
Alanine Aminotransferase (IU/L) 7 days post dose (Day 8)25 ± 11.70
Alanine Aminotransferase (I/UL) 8 days post dose (Day 9)25.6 ± 12.21
Alk Phosphate (IU/L) Baseline64.9 ± 20.51
Alk Phosphate (IU/L)3 days post dose (Day 4)61.0 ± 19.42
Alk Phosphate (IU/L) 7 days post dose (Day 8)66.9 ± 20.90
Alk Phosphate (IU/L) 8 days post dose (Day 9)67.4 ± 20.56
Aspartate Aminotransferase (IU/L) Baseline17.6 ± 4.63
Aspartate Aminotransferase (IU/L) 3 days post dose (Day 4)18.2 ± 5.69
Aspartate Aminotransferase (IU/L) 7 days post dose (Day 8)17.9 ± 4.49
Aspartate Aminotransferase (IU/L) 8 days post dose (Day 9)18.3 ± 4.46
Gamma Glutamyl Transferase (IU/L) Baseline27.4 ± 12.89
Gamma Glutamyl Transferase (IU/L) 3 days post dose (Day 4)27.6 ± 12.81
Gamma Glutamyl Transferase (IU/L) 7 days post dose (Day 8)28.6 ± 12.91
Gamma Glutamyl Transferase (IU/L) 8 days post dose (Day 9)28.6 ± 13.01
Lactate Dehydrogenase (IU/L) Baseline159.2 ± 33.00
Lactate Dehydrogenase (IU/L) 3 days post dose (Day 4)147.8 ± 34.86
Lactate Dehydrogenase (IU/L) 7 days post dose (Day 8)142.9 ± 33.20
Lactate Dehydrogenase (IU/L) 8 days post dose (Day 9)148.1 ± 33.20
SecondaryAlbumin, Globulin, and Protein at Various Time Points Mean (Standard Deviation)

Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline. Central laboratory reference ranges used for all clinical laboratory safety parameters

Time frame:
Day 1 pre dose, 3 days post dose, 7 days post dose and 8 days post dose
Reported as:
Mean · g/L
Albumin, Globulin, and Protein at Various Time Points Mean (Standard Deviation)
g/LTPOXX
Albumin (g/L) Baseline42.4 ± 2.78
Albumin (g/L) 3 days post dose (Day 4)43.4 ± 3.35
Albumin (g/L) 7 days post dose (Day 8)43.5 ± 2.61
Albumin (g/L)8 days post dose (Day 9)44.2 ± 2.73
Globulin (g/L) Baseline27.3 ± 3.87
Globulin (g/L) 3 days post dose (Day 4)29.1 ± 3.53
Globulin (g/L) 7 days post dose (Day 8)28.6 ± 3.78
Globulin (g/L) 8 days post dose (Day 9)28.9 ± 3.81
Protein (g/L) Baseline69.7 ± 5.13
Protein (g/L) 3 days post dose (Day 4)72.4 ± 5.16
Protein (g/L) 7 days post dose (Day 8)72.1 ± 4.46
Protein (g/L) 8 days post dose (Day 9)73.1 ± 4.90
SecondaryAverage Serum Chemistry at Various Time Points; Mean (Standard Deviation)

Table 14.3.2.2.1 Laboratory Results - Serum Chemistry Safety Population Summary tables of observed values and changes from baseline: for serum chemistry laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline. Central laboratory reference ranges used for all clinical laboratory safety parameters

Time frame:
Day 1 pre dose, 3, 7, and 8 days post dose
Reported as:
Mean · mmol/L
Average Serum Chemistry at Various Time Points; Mean (Standard Deviation)
mmol/LTPOXX
Anion Gap (mmol/L) Baseline10.6 ± 1.5
Anion Gap (mmol/L) 3 days post dose (Day 4)10.4 ± 2.15
Anion Gap (mmol/L) 7 days post dose (Day 8)10.6 ± 1.65
Anion Gap (mmol/L) 8 days post dose (Day 9)10.3 ± 1.38
Blood Urea Nitrogen (mmol/L) Baseline4.415 ± 1.05
Blood Urea Nitrogen (mmol/L) 3 days post dose (Day 4)4.231 ± 0.7147
Blood Urea Nitrogen (mmol/L) 7 days post dose (Day 8)4.091 ± 0.6397
Blood Urea Nitrogen (mmol/L) 8 days post dose (Day 9)4.346 ± 0.6745
Calcium (mmol/L) Baseline2.304 ± 0.0980
Calcium (mmol/L) 3 days post dose (Day 4)2.360 ± 0.0921
Calcium (mmol/L) 7 days post dose (Day 8)2.397 ± 0.0921
Calcium (mmol/L) 8 days post dose (Day 9)2.348 ± 0.0852
Carbon Dioxide (mmol/L) Baseline29.2 ± 1.47
Carbon Dioxide (mmol/L) 3 days post dose (Day 4)29.5 ± 2.02
Carbon Dioxide (mmol/L) 7 days post dose (Day 8)29.8 ± 1.55
Carbon Dioxide (mmol/L) 8 days post dose (Day 9)29.4 ± 1.78
Chloride (mmol/L) Baseline102.6 ± 1.48
Chloride (mmol/L) 3 days post dose (Day 4)103.0 ± 1.55
Chloride (mmol/L) 7 days post dose (Day 8)102.2 ± 1.68
Chloride (mmol/L) 8 days post dose (Day 9)101.9 ± 1.56
Glucose (mmol/L) Baseline5.401 ± 0.4533
Glucose (mmol/L) 3 days post dose (Day 4)5.276 ± 0.4118
Glucose (mmol/L) 7 days post dose (Day 8)5.088 ± 0.4252
Glucose (mmol/L) 8 days post dose (Day 9)5.169 ± 0.3683
Phosphate (mmol/L) Baseline1.115 ± 0.1642
Phosphate (mmol/L) 3 days post dose (Day 4)1.246 ± 0.1668
Phosphate (mmol/L) 7 days post dose (Day 8)1.282 ± 0.1600
Phosphate (mmol/L) 8 days post dose (Day 9)1.104 ± 0.1363
Potassium (mmol/L) Baseline4.12 ± 0.263
Potassium (mmol/L) 3 days post dose (Day 4)4.15 ± 0.230
Potassium (mmol/L) 7 days post dose (Day 8)4.17 ± 0.244
Potassium (mmol/L) 8 days post dose (Day 9)4.13 ± 0.303
Sodium (mmol/L) Baseline138.2 ± 1.57
Sodium (mmol/L) 3 days post dose (Day 4)138.9 ± 1.62
Sodium (mmol/L) 7 days post dose (Day 8)138.5 ± 1.69
Sodium (mmol/L) 8 days post dose (Day 9)137.4 ± 1.88
SecondaryUrobilinogen (Umol/dl) 8 Days Post Dose (Day 9); Mean (Standard Deviation)

Table 14.3.2.3.2 Laboratory Results - Urinalysis Safety Population Summary tables of observed values and changes from baseline: for urinalysis laboratory tests with numeric values for subjects in the Safety Population; to each scheduled post-baseline and changes in low, normal, high, and abnormal were summarized comparing the results at each scheduled post-baseline visit. Central laboratory reference ranges used for all clinical laboratory safety parameters.

Time frame:
8 days post dose
Reported as:
Mean · umol/dl
Urobilinogen (Umol/dl) 8 Days Post Dose (Day 9); Mean (Standard Deviation)
umol/dlTPOXX
Urobilinogen (Umol/dl) 8 Days Post Dose (Day 9); Mean (Standard Deviation)1.0196 ± 0.00640
Secondary12-lead ECG Heart Rate at 9 Day Time Point; Mean (Standard Deviation)

Table 14.3.4.1.1 Electrocardiogram Results Safety Population Data listed shows the mean and standard deviation of 12 Lead EKG heart rate for 34 participants on day 9.

Time frame:
9 days
Reported as:
Mean · bats per minute
12-lead ECG Heart Rate at 9 Day Time Point; Mean (Standard Deviation)
bats per minuteTPOXX
12-lead ECG Heart Rate at 9 Day Time Point; Mean (Standard Deviation)71.0 ± 9.66

Adverse events

Collected over Adverse events were collected from first dose of study drug until study Day 37 (+2 days).. Non-serious events are listed at a 2.9% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TPOXX0/34 (0%)0/34 (0%)12/34 (35.3%)
Most frequent other events
Most frequent other events
EventTPOXX
HeadacheNervous system disorders2/34
NauseaGastrointestinal disorders2/34
Infrequent bowel movementsGastrointestinal disorders1/34
Lip dryGastrointestinal disorders1/34
Scleral hyperaemiaEye disorders1/34
Urinary tract infectionInfections and infestations1/34
Palate injuryInjury, poisoning and procedural complications1/34
Back painMusculoskeletal and connective tissue disorders1/34
DysuriaRenal and urinary disorders1/34
Dermatitis contactSkin and subcutaneous tissue disorders1/34

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)TPOXX
<=18 years0
Between 18 and 65 years34
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)TPOXX
Female11
Male23
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TPOXX
Hispanic or Latino5
Not Hispanic or Latino29
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TPOXX
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American22
White12
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)TPOXX
United States34
Weight
Weight(kg)TPOXX
Mean138.13 ± 20.881
Height
Height(cm)TPOXX
Mean176.40 ± 9.649
08

Study locations

1 site
  • PPD Phase I Clinic
    Austin, Texas 78744, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04392739
Lead sponsor
SIGA Technologies
Collaborators
Biomedical Advanced Research and Development Authority, PPD Development, LP
Responsible party
Sponsor
First posted
May 19, 2020
Start date
Jul 19, 2019
Primary completion
Dec 5, 2019
Completion
Dec 5, 2019
Results posted
Sep 19, 2024
Last update
Sep 11, 2026

Study contacts

Dennis Hruby, PhD
study director · SIGA Chief Scientific Officer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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