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EDP-235 SAD Cohorts for COVID-19
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 14 days in hv mad cohorts
Awards & highlights
Study Summary
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-235 in healthy adult subjects.
Eligible Conditions
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 days in hv mad cohorts
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days in hv mad cohorts
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety measured by adverse events
Secondary outcome measures
AUC of EDP-235
Cmax of EDP-235
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: EDP-235 SAD CohortsExperimental Treatment1 Intervention
EDP-235 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5, orally, once daily in one single administration
Group II: EDP-235 MAD CohortsExperimental Treatment1 Intervention
EDP-235 Dose 1, Dose 2 and Dose 3 orally, once daily for 7 days
Group III: EDP-235 SAD Placebo CohortsPlacebo Group1 Intervention
Matching placebo, orally, once daily in one single administration
Group IV: EDP-235 MAD Placebo CohortsPlacebo Group1 Intervention
Matching placebo, orally, once daily for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP-235
2022
Completed Phase 1
~140
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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
2,276 Total Patients Enrolled
Enanta Pharmaceuticals, IncLead Sponsor
39 Previous Clinical Trials
2,912 Total Patients Enrolled
3 Trials studying COVID-19
260 Patients Enrolled for COVID-19
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