SmallpoxPhase 1BCV-001NCT05935917
Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults
A Phase 1 study testing Brincidofovir in people with Smallpox, run by Emergent BioSolutions at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate whether both Form H and Form II, 100mg brincidofovir tablets are bioequivalent, when given under fasting conditions in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- Brincidofovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2023to 27 Sep 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to provide informed consent voluntarily signed by participant.
- Male or female between 18 to 70 years of age, inclusive at screening.
- Body mass index (BMI) from 18 to 32 kg/m² with a minimum body weight of ≥ 50 kg, inclusive at screening.
- Women must be of nonchildbearing potential, i.e., postmenopausal woman (defined as spontaneous amenorrhea for 1-year prior to Period 1 Day 1) with a confirmed follicle stimulating hormone (FSH) level in laboratory's "postmenopausal" reference range; or a premenopausal woman documented as surgically sterile following either a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, tubal ligation.
- Males must be surgically sterilized (confirmed by documented azoospermia at least 90 days after procedure).
- Overtly healthy as determined by medical evaluation and judgment of the investigator including medical history, physical examination (PE), laboratory tests, vital signs (VS), and eletrocardiogram (ECG) at screening and Day -1. [Note: hematology, serum chemistry, and urinalysis parameters must fall within the laboratory's normal reference ranges or have been determined by the investigator to have no clinical significance in the context of this study.] Except:
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- Alanine transaminase (ALT), aspartate aminotransferase (AST) and gammaglutamyl transferase (GGT) x ≤1.5 upper limit of normal reference range (ULN)
- Total Bilirubin x ≤1.5 ULN
- Hemoglobin (Hb) ≥10.5 g/dL for females or ≥12 g/dL for males
- Able to comply with the dosing instructions and available to complete the study schedule of assessments.
Who cannot join
- History or current symptoms of any serious psychiatric illness, including addiction, which could interfere with participant treatment, assessment, or compliance with the protocol.
- History of chronic liver disease or hepatic impairment, including but not limited to alcoholic liver disease, chronic viral hepatitis, autoimmune hepatitis, steatosis, or hemochromatosis. Note: A remote (≥12 months prior to screening) history of hepatitis A infection will not be cause for exclusion.
- History of Gilbert's syndrome or current evidence of the disease based on laboratory information at screening visit or Day -1.
- History of hematological disorders, including disorders such as a bleeding disorder or a risk of gastrointestinal bleeding.
- Clinically significant history of difficulty with blood donation, including vasovagal syncope (fainting), and/or poor venous access for the purposes of phlebotomy.
- Positive (reactive) serological test result at the screening evaluation consistent with possible infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus type 1 or 2 (HIV).
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- Positive test for drugs of abuse and/or alcohol at either screening or check-in days.
- Clinically significant infection (e.g., COVID-19, cold, flu, or febrile illness) within 14 days prior to Period 1 Day 1.
- Donated a unit of blood or had clinically significant blood loss within 30 days prior to Period 1 Day 1 or donated plasma within 14 days prior to Period 1 Day 1.
- Received any investigational drug, agent, or device within 30 days prior to Period 1 Day 1, or current participation in another interventional study.
- Consumed any fruit juice including grapefruit juice, pomegranate juice, cranberry juice, orange juice, and Seville orange juice (also known as sour, bitter or bigarade orange) within 3 days prior to Period 1 Day 1 and throughout the study, unless prior approval is granted by both the investigator and the medical monitor.
- Received any medication or herbal product (e.g., St. John's wort) known to induce or inhibit hepatic metabolizing enzymes and/or transporters within 30 days or 5 half-lives of the compound, whichever is longer, prior to Period 1 Day 1 and throughout the study, unless approval is granted by both the investigator and the medical monitor.
- Received any vaccines (including COVID-19 vaccine) within 14 days prior to Period 1 Day 1 and throughout the study, unless approval is granted by both the investigator and the medical monitor.
- Any condition or set of circumstances that, in the judgment of the investigator, could interfere with the participant's ability to comply with the dosing schedule and completion of the study evaluations (e.g., participants who are unable to communicate or cooperate with the investigator).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single-dose, Randomized, Two-period, Crossover Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adult Participants
The goal of this clinical trial is to evaluate whether both Form H and Form II, 100mg brincidofovir tablets are bioequivalent, when given under fasting conditions in healthy adults.
Participants will be randomized to each receive one tablet of Form H and one tablet of Form II,14 days apart and undergo pharmacokinetic testing pre-dose and post-dose to evaluate safety. This is an open-label, single-dose, randomized, two-period, crossover study.
Read the detailed description
Primary Objectives:
- To evaluate the bioequivalence (BE) of brincidofovir (BCV) hydrate (Form H) tablet and the Form II tablet when administered under fasting conditions in healthy adult participants.
- To characterize plasma BCV pharmacokinetics (PK) following single doses of BCV when administered in healthy adult participants.
Safety Objective:
- To evaluate the safety of BCV following administration of single dose of 100 mg BCV Form H and BCV Form II tablet in healthy adult participants.
- Conditions
- Smallpox
- Being tested
- Brincidofovir
- Keywords
- Smallpox, Pharmacokinetics (PK), Bioequivalence (BE), Orthopox, CMX001-129
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrincidofovirDrug
Also called CMX001-129
100 mg tablet of Form H and 100 mg tablet of Form II
| Study group | Role | What they receive |
|---|---|---|
| Treatment AB - Form H (test tablet) first | Active comparator | Treatment AB:
Participants assigned to Treatment AB in Period 1, will be given a single 100 mg tablet of Form H (test tablet). In Period 2, participants will be given a single 100 mg tablet of Form II (reference tablet) after a 14 day washout period. Receives: Drug: Brincidofovir |
| Treatment BA - Form II (reference tablet) first | Active comparator | Treatment BA:
Participants assigned to Treatment BA in Period 1, will be given a single 100 mg tablet of Form II (reference tablet). In Period 2, participants will be given a single 100 mg tablet of Form H (test tablet) after a 14 day washout period. Receives: Drug: Brincidofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK endpoint - Peak Plasma Concentration (Cmax)
Assess maximum observed plasma concentration of Brincidofovir
Measured: Through 96 hours post-dose
PK endpoint - AUClast
Assess area under the plasma concentration-time curve from time 0 to time of the last measurable concentration (AUC 0 - last) of Brincidofovir
Measured: Through 96 hours post-dose
PK endpoint - AUCinf
Assess area under the plasma concentration-time curve from time 0 to infinity (AUC 0 - inf) of Brincidofovir
Measured: Through 96 hours post-dose
Incidence of treatment adverse events (AEs)
Incidence of treatment-emergent AEs, treatment-related AEs, severe AEs, AEs leading to withdrawal and serious adverse events
Measured: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Heart Rate
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal heart rate
Measured: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Respiratory Rate
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal respiratory rate
Measured: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal Systolic Blood Pressure
Measured: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary abnormal Body Temperature (Celsius)
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal body temperature
Measured: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: Total Protein, Albumin, Globulin (g/dL)
Descriptive statistical summary (summarized by treatment, study day, and time) of Total Protein, Albumin, Globulin
Measured: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: Albumin/Globulin ratio
Descriptive statistical summary (summarized by treatment, study day, and time) of albumin/globulin ratio
Measured: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: alkaline phosphatase, ALT, AST, GGT and Creatine phosphokinase (U/L)
Descriptive statistical summary (summarized by treatment, study day, and time) of alkaline phosphatase, ALT, AST, GGT and Creatine phosphokinase
Measured: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: bilirubin (total and direct), BUN, serum calcium, glucose (random), serum phosphate, serum uric acid and serum magnesium (mg/dL)
Descriptive statistical summary (summarized by treatment, study day, and time) of bilirubin (total and direct), BUN, serum calcium, glucose (random), serum phosphate, serum uric acid and serum magnesium
Measured: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameters: serum chloride, CO2, serum sodium and serum potassium (mmol/L)
Descriptive statistical summary (summarized by treatment, study day, and time) of serum chloride, CO2, serum sodium and serum potassium
Measured: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: Creatinine (g/24h)
Descriptive statistical summary (summarized by treatment, study day, and time) of creatinine
Measured: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: eGFR (ml/min)
Descriptive statistical summary (summarized by treatment, study day, and time) of eGFR
Measured: Through end of study visit (within 14 days after 2nd dose)
Chemistry parameter: LDH (units/L)
Descriptive statistical summary (summarized by treatment, study day, and time) of LDH
Measured: Through end of study visit (within 14 days after 2nd dose)
Hematology parameters: basophils, eosinophils, lymphocytes, monocytes and neutrophils (cells/uL)
Descriptive statistical summary (summarized by treatment, study day, and time) of basophils, eosinophils lymphocytes, monocytes and neutrophils
Measured: Through end of study visit (within 14 days after 2nd dose)
Hematology parameters: leukocytes and platelets (thousand/uL)
Descriptive statistical summary (summarized by treatment, study day, and time) of leukocytes and platelets
Measured: Through end of study visit (within 14 days after 2nd dose)
Hematology parameters: proportion of basophils, eosinophils, lymphocytes, monocytes and neutrophils
Descriptive statistical summary (summarized by treatment, study day, and time) of basophils/leukocytes, eosinophils//leukocytes, lymphocytes//leukocytes, monocytes//leukocytes and neutrophils//leukocytes
Measured: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: erythrocytes (million/uL)
Descriptive statistical summary (summarized by treatment, study day, and time) of erythrocytes
Measured: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: erythrocytes mean corpuscular volume (MCV) (fL)
Descriptive statistical summary (summarized by treatment, study day, and time) of erythrocytes MCV
Measured: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: hematocrit (%)
Descriptive statistical summary (summarized by treatment, study day, and time) of hematocrit
Measured: Through end of study visit (within 14 days after 2nd dose)
Hematology parameter: hemoglobin (g/dL)
Descriptive statistical summary (summarized by treatment, study day, and time) of hemoglobin
Measured: Through end of study visit (within 14 days after 2nd dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start30 May 2023
- Primary completion14 Aug 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmallpoxStudies 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
- Crossover
- Model description
- This is an open-label, single-dose, randomized, two-period, crossover study to evaluate BE of BCV plasma PK parameters after administration of single 100 mg doses of BCV using the Form H (test tablet) and Form II (reference tablet) under fasting conditions in normal healthy adults. The study will also evaluate the safety of BCV following administration of two 100 mg single doses of BCV. Eligible participants will be randomized in a 1:1 ratio to one of two treatment sequences, Treatment AB or Treatment BA.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergent BioSolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Cassie, MSc, Study director, Director, Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935917
- Sponsor's protocol ID
- EBS-BCV-001
- Acronym
- BCV-001
- Status last verified
- Jan 2025
- First submitted
- 5 Jun 2023
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose, Randomized, Two-period, Crossover Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05935917
- Acronym / sponsor ID
- BCV-001 / EBS-BCV-001
- Conditions
- Smallpox
- Keywords
- Smallpox, Pharmacokinetics (PK), Bioequivalence (BE), Orthopox, CMX001-129
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Emergent BioSolutionsIndustry (pharma, biotech, devices)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether both Form H and Form II, 100mg brincidofovir tablets are bioequivalent, when given under fasting conditions in healthy adults.
Participants will be randomized to each receive one tablet of Form H and one tablet of Form II,14 days apart and undergo pharmacokinetic testing pre-dose and post-dose to evaluate safety. This is an open-label, single-dose, randomized, two-period, crossover study.
Detailed description
Primary Objectives:
- To evaluate the bioequivalence (BE) of brincidofovir (BCV) hydrate (Form H) tablet and the Form II tablet when administered under fasting conditions in healthy adult participants.
- To characterize plasma BCV pharmacokinetics (PK) following single doses of BCV when administered in healthy adult participants.
Safety Objective:
- To evaluate the safety of BCV following administration of single dose of 100 mg BCV Form H and BCV Form II tablet in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, single-dose, randomized, two-period, crossover study to evaluate BE of BCV plasma PK parameters after administration of single 100 mg doses of BCV using the Form H (test tablet) and Form II (reference tablet) under fasting conditions in normal healthy adults. The study will also evaluate the safety of BCV following administration of two 100 mg single doses of BCV. Eligible participants will be randomized in a 1:1 ratio to one of two treatment sequences, Treatment AB or Treatment BA.
| Arm | Type | Receives |
|---|---|---|
| Treatment AB - Form H (test tablet) first | Active comparator | Drug: BrincidofovirTreatment AB: Participants assigned to Treatment AB in Period 1, will be given a single 100 mg tablet of Form H (test tablet). In Period 2, participants will be given a single 100 mg tablet of Form II (reference tablet) after a 14 day washout period. |
| Treatment BA - Form II (reference tablet) first | Active comparator | Drug: BrincidofovirTreatment BA: Participants assigned to Treatment BA in Period 1, will be given a single 100 mg tablet of Form II (reference tablet). In Period 2, participants will be given a single 100 mg tablet of Form H (test tablet) after a 14 day washout period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to provide informed consent voluntarily signed by participant.
- Male or female between 18 to 70 years of age, inclusive at screening.
- Body mass index (BMI) from 18 to 32 kg/m² with a minimum body weight of ≥ 50 kg, inclusive at screening.
- Women must be of nonchildbearing potential, i.e., postmenopausal woman (defined as spontaneous amenorrhea for 1-year prior to Period 1 Day 1) with a confirmed follicle stimulating hormone (FSH) level in laboratory's "postmenopausal" reference range; or a premenopausal woman documented as surgically sterile following either a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, tubal ligation.
- Males must be surgically sterilized (confirmed by documented azoospermia at least 90 days after procedure).
Key exclusion criteria (14 listed)
- History or current symptoms of any serious psychiatric illness, including addiction, which could interfere with participant treatment, assessment, or compliance with the protocol.
- History of chronic liver disease or hepatic impairment, including but not limited to alcoholic liver disease, chronic viral hepatitis, autoimmune hepatitis, steatosis, or hemochromatosis. Note: A remote (≥12 months prior to screening) history of hepatitis A infection will not be cause for exclusion.
- History of Gilbert's syndrome or current evidence of the disease based on laboratory information at screening visit or Day -1.
- History of hematological disorders, including disorders such as a bleeding disorder or a risk of gastrointestinal bleeding.
- Clinically significant history of difficulty with blood donation, including vasovagal syncope (fainting), and/or poor venous access for the purposes of phlebotomy.
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 |
|---|---|---|
| BrincidofovirAlso: CMX001-129100 mg tablet of Form H and 100 mg tablet of Form II | Drug | Treatment AB - Form H (test tablet) first, Treatment BA - Form II (reference tablet) first |
Primary outcome
PK endpoint - Peak Plasma Concentration (Cmax)
Time frame: Through 96 hours post-dose
Assess maximum observed plasma concentration of Brincidofovir
PK endpoint - AUClast
Time frame: Through 96 hours post-dose
Assess area under the plasma concentration-time curve from time 0 to time of the last measurable concentration (AUC 0 - last) of Brincidofovir
PK endpoint - AUCinf
Time frame: Through 96 hours post-dose
Assess area under the plasma concentration-time curve from time 0 to infinity (AUC 0 - inf) of Brincidofovir
Incidence of treatment adverse events (AEs)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Incidence of treatment-emergent AEs, treatment-related AEs, severe AEs, AEs leading to withdrawal and serious adverse events
Descriptive statistical summary abnormal Heart Rate
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal heart rate
Descriptive statistical summary abnormal Respiratory Rate
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal respiratory rate
Descriptive statistical summary abnormal Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal Systolic Blood Pressure
Descriptive statistical summary abnormal Body Temperature (Celsius)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of abnormal body temperature
Chemistry parameters: Total Protein, Albumin, Globulin (g/dL)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of Total Protein, Albumin, Globulin
Chemistry parameter: Albumin/Globulin ratio
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of albumin/globulin ratio
Chemistry parameters: alkaline phosphatase, ALT, AST, GGT and Creatine phosphokinase (U/L)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of alkaline phosphatase, ALT, AST, GGT and Creatine phosphokinase
Chemistry parameters: bilirubin (total and direct), BUN, serum calcium, glucose (random), serum phosphate, serum uric acid and serum magnesium (mg/dL)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of bilirubin (total and direct), BUN, serum calcium, glucose (random), serum phosphate, serum uric acid and serum magnesium
Chemistry parameters: serum chloride, CO2, serum sodium and serum potassium (mmol/L)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of serum chloride, CO2, serum sodium and serum potassium
Chemistry parameter: Creatinine (g/24h)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of creatinine
Chemistry parameter: eGFR (ml/min)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of eGFR
Chemistry parameter: LDH (units/L)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of LDH
Hematology parameters: basophils, eosinophils, lymphocytes, monocytes and neutrophils (cells/uL)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of basophils, eosinophils lymphocytes, monocytes and neutrophils
Hematology parameters: leukocytes and platelets (thousand/uL)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of leukocytes and platelets
Hematology parameters: proportion of basophils, eosinophils, lymphocytes, monocytes and neutrophils
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of basophils/leukocytes, eosinophils//leukocytes, lymphocytes//leukocytes, monocytes//leukocytes and neutrophils//leukocytes
Hematology parameter: erythrocytes (million/uL)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of erythrocytes
Hematology parameter: erythrocytes mean corpuscular volume (MCV) (fL)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of erythrocytes MCV
Hematology parameter: hematocrit (%)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of hematocrit
Hematology parameter: hemoglobin (g/dL)
Time frame: Through end of study visit (within 14 days after 2nd dose)
Descriptive statistical summary (summarized by treatment, study day, and time) of hemoglobin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Dave Cassie, MSc study director
Director, 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 Brincidofovir in people with Smallpox, run by Emergent BioSolutions 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 10 inclusion and 14 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: finished, as of the sponsor's last update on 15 Jan 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PK endpoint - Peak Plasma Concentration (Cmax) (time frame: Through 96 hours post-dose). The study lists 23 primary outcomes in all. 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 15 Jan 2025.