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Nucleoside Reverse Transcriptase Inhibitor

EDP-514 HV MAD Cohorts for Hepatitis B Virus Infections

Phase 1
Waitlist Available
Research Sponsored by Enanta Pharmaceuticals
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 up to 5 years

Summary

This trial will assess the safety and efficacy of EDP-514, a new drug for Hepatitis B, in two parts. In the first part, healthy adults will take the drug to assess safety and tolerability. In the second part, patients with chronic Hepatitis B will take the drug to assess its ability to fight the virus.

Eligible Conditions
  • Hepatitis B Virus Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: EDP-514 HV SAD CohortsExperimental Treatment1 Intervention
EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration
Group II: EDP-514 HV MAD CohortsExperimental Treatment1 Intervention
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days
Group III: EDP-514 HBV MAD CohortsExperimental Treatment1 Intervention
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days
Group IV: EDP-514 HV MAD Placebo CohortPlacebo Group1 Intervention
Matching placebo, orally, once daily for 14 days
Group V: EDP-514 HBV MAD Placebo CohortPlacebo Group1 Intervention
Matching placebo, orally, once daily for 28 days
Group VI: EDP-514 HV SAD Placebo CohortPlacebo Group1 Intervention
Matching placebo, orally, once daily in one single administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP-514
2020
Completed Phase 1
~200

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Enanta PharmaceuticalsLead Sponsor
33 Previous Clinical Trials
2,255 Total Patients Enrolled
Pharmaceutical Research AssociatesOTHER
17 Previous Clinical Trials
12,965 Total Patients Enrolled
Enanta Pharmaceuticals, IncLead Sponsor
40 Previous Clinical Trials
3,022 Total Patients Enrolled
~16 spots leftby Nov 2025
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