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Anti-viral

Treatment AB - Form H (test tablet) first for Smallpox (BCV-001 Trial)

Phase 1
Waitlist Available
Research Sponsored by Emergent BioSolutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through end of study visit (within 14 days after 2nd dose)
Awards & highlights

BCV-001 Trial Summary

This trial will test if two forms of a drug are safe & effective when given to healthy adults. Participants will take different forms of the drug 14 days apart & be tested to measure safety.

BCV-001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through end of study visit (within 14 days after 2nd dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of study visit (within 14 days after 2nd dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Chemistry parameter: Albumin/Globulin ratio
Chemistry parameter: Creatinine (g/24h)
Chemistry parameter: LDH (units/L)
+20 more

BCV-001 Trial Design

2Treatment groups
Active Control
Group I: Treatment AB - Form H (test tablet) firstActive Control1 Intervention
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.
Group II: Treatment BA - Form II (reference tablet) firstActive Control1 Intervention
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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Emergent BioSolutionsLead Sponsor
61 Previous Clinical Trials
937,400 Total Patients Enrolled
8 Trials studying Smallpox
920,203 Patients Enrolled for Smallpox
Dave Cassie, MScStudy DirectorDirector, Clinical Research

Media Library

Brincidofovir (Anti-viral) Clinical Trial Eligibility Overview. Trial Name: NCT05935917 — Phase 1
Smallpox Research Study Groups: Treatment AB - Form H (test tablet) first, Treatment BA - Form II (reference tablet) first
Smallpox Clinical Trial 2023: Brincidofovir Highlights & Side Effects. Trial Name: NCT05935917 — Phase 1
Brincidofovir (Anti-viral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05935917 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining opportunities to join this medical experiment?

"Affirmative, the data on clinicaltrials.gov states that this research endeavour is currently enlisting participants. It was initially posted on May 30th 2023 and edited for the last time July 5th 2023. 44 patients are being sought after across 1 medical facility."

Answered by AI

Do I qualify to participate in this clinical research?

"The current clinical trial is accepting 44 applicants who have smallpox and are between 18-70 years of age."

Answered by AI

What is the participant count for this clinical trial?

"Affirmative. Clinicaltrials.gov's records confirm that this clinical trial is still in its recruitment period, which began on May 30th 2023 and was last updated July 5th of the same year. 44 patients are needed to be recruited at a single location for this study."

Answered by AI

Does this experiment allow for participants aged 70 and over?

"The age requirements for participants in this clinical trial necessitate that potential patients are between 18 and 70 years of age."

Answered by AI

Is Treatment AB - Form H (test tablet) viable for human use?

"Treatment AB - Form H (test tablet) has only been subject to limited testing, so its safety is ranked as 1 on a scale of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults
2023. "Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05935917.
~24 spots leftby Apr 2025
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