Filovirus InfectionsPhase 1NCT02319772
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BCX4430
A Phase 1 study testing BCX4430 in people with Filovirus Infections and Ebola Virus Infection, run by BioCryst Pharmaceuticals at 1 site in United Kingdom.
Trial summary
This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2 subjects will receive BCX4430 for 7 days. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Filovirus Infections, Ebola Virus Infection
- What is being tested?
- BCX4430
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to Apr 2016
- 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
- Weight ≥ 50 kg (110 lbs) and ≤ 100 kg (220 lbs)
- Body mass index (BMI) of 19-32 kg/m2
- Willing to abstain from alcohol consumption for a period of 2 days prior to and during the study
- Sexually active women of child bearing potential and sexually active men must utilize 2 highly effective contraceptive methods
- Abstain from caffeinated beverages
- Normal vital signs at rest
- Ability to provide written informed consent
Who cannot join
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Participation in a clinical research study within the previous 90 days
- Any medical condition or medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participation for that subject
- Any screening laboratory test with an abnormal result that is grade 1 (mild) or greater
- Abnormal ECG (defined as any screening or baseline QTc>450 msec, PR > 200 msec, or ventricular and/or atrial premature contractions that are more frequent than occasional, and/or as couplets or higher in grouping
- An abnormal cardiovascular exam including a confirmed elevated blood pressure at screening (systolic greater than 140, diastolic greater than 90) after 5 minutes of supine rest, tachycardia >100 bpm after 5 minutes of supine rest
Show all 17Show fewer
- Family or personal history of sudden death or QT prolongation
- Use of prescription, over-the-counter (OTC) medications or herbal supplements, with the exception of acetaminophen and non-oral hormonal contraception, for a period of 7 days prior to and during the study
- Inadequate muscle mass to receive IM injections
- History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse
- Current smokers or history of smoking within the last 12 months
- Serious adverse reaction or serious hypersensitivity to any drug
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
- Pregnant or nursing females
- Male subjects with pregnant female partners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BCX4430 Administered Via Intramuscular Injection (IM) in Healthy Subjects
This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2 subjects will receive BCX4430 for 7 days.
Read the detailed description
Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics of single, ascending doses of BCX4430 versus placebo in healthy subjects. Up to 6 ascending dose cohorts will be enrolled in a sequential manner. Eight subjects will be treated with a single dose of study drug per dose cohort: 6 subjects per cohort will receive BCX4430, and 2 subjects per cohort will receive matching placebo.
Part 2 of the study will be initiated following review of all available data from Part 1 by an independent Safety Monitoring Committee
Part 2 of the study will evaluate the safety, tolerability, and pharmacokinetics of 7 days of daily dosing with BCX4430 versus placebo in healthy subjects. Up to 4 ascending dose cohorts will be treated in a sequential manner. Ten subjects will be treated with study drug per dose cohort (8 subjects will receive BCX4430 and 2 subjects will receive placebo per cohort). The planned doses and dosing regimens for each of the Part 2 cohorts will be determined based upon data collected during Part 1.
- Conditions
- Filovirus Infections, Ebola Virus Infection
- Being tested
- BCX4430, Placebo
- Keywords
- Healthy volunteers, Ebola virus, Filovirus
- Medical subject headings
- Filoviridae Infections, Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCX4430Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| BCX4430 | Experimental | BCX4430 administered as an IM injection Receives: Drug: BCX4430 |
| Placebo | Placebo comparator | Matched placebo administered as an IM injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, measured by the frequency and severity of adverse events, laboratory abnormalities and other safety parameters following single (Part 1) and multiple (Part 2) doses of BCX4430
Evaluation of the incidence and severity of adverse events, laboratory abnormalities, ECG findings, vital sign changes, injection site and physical examination findings
Measured: Part 1: 7 days. Part 2: 14 days
Secondary outcomes (2)
Plasma exposure of BCX4430, determined by the concentration time profile and PK parameters following single (Part 1) and multiple (Part 2) doses of BCX4430
Measured: Part 1: 7 days. Part 2: 14 days
The urinary elimination of BCX4430, determined by the concentration of drug following single (Part 1) and multiple (Part 2) doses of BCX4430
Measured: Part 1: 7 days. Part 2: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Filovirus InfectionsStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jo Collier, MBChB, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319772
- Sponsor's protocol ID
- BCX4430-101
- Other IDs
- DMID 14-0030
- Status last verified
- Jul 2016
- First submitted
- 11 Dec 2014
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mathis A, Collins D, Dobo S, Walling DM, Sheridan WP, Taylor R. Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2022 Apr;11(4):467-474. doi: 10.1002/cpdd.1037. Epub 2022 Feb 19.
PubMed 35182042
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BCX4430 Administered Via Intramuscular Injection (IM) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02319772
- Acronym / sponsor ID
- BCX4430-101
- Conditions
- Filovirus Infections, Ebola Virus Infection
- Keywords
- Healthy volunteers, Ebola virus, Filovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Dec 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Dec 2014 (estimated)
- 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.
This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of BCX4430 administered via intramuscular (IM) injection in healthy subjects. In part 1, subjects will receive a single dose of BCX4430; in part 2 subjects will receive BCX4430 for 7 days.
Detailed description
Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics of single, ascending doses of BCX4430 versus placebo in healthy subjects. Up to 6 ascending dose cohorts will be enrolled in a sequential manner. Eight subjects will be treated with a single dose of study drug per dose cohort: 6 subjects per cohort will receive BCX4430, and 2 subjects per cohort will receive matching placebo.
Part 2 of the study will be initiated following review of all available data from Part 1 by an independent Safety Monitoring Committee
Part 2 of the study will evaluate the safety, tolerability, and pharmacokinetics of 7 days of daily dosing with BCX4430 versus placebo in healthy subjects. Up to 4 ascending dose cohorts will be treated in a sequential manner. Ten subjects will be treated with study drug per dose cohort (8 subjects will receive BCX4430 and 2 subjects will receive placebo per cohort). The planned doses and dosing regimens for each of the Part 2 cohorts will be determined based upon data collected during Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCX4430 | Experimental | Drug: BCX4430BCX4430 administered as an IM injection |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo administered as an IM injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Weight ≥ 50 kg (110 lbs) and ≤ 100 kg (220 lbs)
- Body mass index (BMI) of 19-32 kg/m2
- Willing to abstain from alcohol consumption for a period of 2 days prior to and during the study
- Sexually active women of child bearing potential and sexually active men must utilize 2 highly effective contraceptive methods
- Abstain from caffeinated beverages
Key exclusion criteria (17 listed)
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Participation in a clinical research study within the previous 90 days
- Any medical condition or medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's ability to participate in the study or increase the risk of participation for that subject
- Any screening laboratory test with an abnormal result that is grade 1 (mild) or greater
- Abnormal ECG (defined as any screening or baseline QTc>450 msec, PR > 200 msec, or ventricular and/or atrial premature contractions that are more frequent than occasional, and/or as couplets or higher in grouping
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 |
|---|---|---|
| BCX4430 | Drug | BCX4430 |
| Placebo | Drug | Placebo |
Primary outcome
Safety, measured by the frequency and severity of adverse events, laboratory abnormalities and other safety parameters following single (Part 1) and multiple (Part 2) doses of BCX4430
Time frame: Part 1: 7 days. Part 2: 14 days
Evaluation of the incidence and severity of adverse events, laboratory abnormalities, ECG findings, vital sign changes, injection site and physical examination findings
2 secondary outcomes
Plasma exposure of BCX4430, determined by the concentration time profile and PK parameters following single (Part 1) and multiple (Part 2) doses of BCX4430
Time frame: Part 1: 7 days. Part 2: 14 days
The urinary elimination of BCX4430, determined by the concentration of drug following single (Part 1) and multiple (Part 2) doses of BCX4430
Time frame: Part 1: 7 days. Part 2: 14 days
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 7 Jul 2016.
- Derived from this study: PubMed 35182042Mathis A, Collins D, Dobo S, Walling DM, Sheridan WP, Taylor R. Pharmacokinetics and Safety of the Nucleoside Analog Antiviral Drug Galidesivir Administered to Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2022 Apr;11(4):467-474. doi: 10.1002/cpdd.1037. Epub 2022 Feb 19.
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.
Jo Collier, MBChB principal investigator
Quotient Clinical
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 BCX4430 in people with Filovirus Infections and Ebola Virus Infection, run by BioCryst Pharmaceuticals at 1 site in United Kingdom.
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 7 inclusion and 17 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 7 Jul 2016. 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 Kingdom. 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?
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?
Safety, measured by the frequency and severity of adverse events, laboratory abnormalities and other safety parameters following single (Part 1) and multiple (Part 2) doses of BCX4430 (time frame: Part 1: 7 days. Part 2: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319772, which also lists 1 linked publication.
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 7 Jul 2016; AzTrials last refreshed its copy on 29 Oct 2026.