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EDP-323 SAD Cohorts for Respiratory Syncytial Virus
Phase 1
Waitlist Available
Research Sponsored by Enanta Pharmaceuticals, Inc
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 mad cohorts
Awards & highlights
Study Summary
This trial tests the safety of a new drug in healthy adults. It will measure how the body processes the drug and how it is tolerated.
Eligible Conditions
- Respiratory Syncytial Virus (RSV)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 days in mad cohorts
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 days in 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-323
Cmax of EDP-323
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: EDP-323 SAD CohortsExperimental Treatment1 Intervention
EDP-323 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6, orally, once daily in one single administration
Group II: EDP-323 MAD CohortsExperimental Treatment1 Intervention
EDP-323 Dose 1, Dose 2, Dose 3 and Dose 4 orally, once daily for 7 days
Group III: EDP-323 SAD Placebo CohortsPlacebo Group1 Intervention
Matching placebo, orally, once daily in one single administration
Group IV: EDP-323 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-323
2022
Completed Phase 1
~90
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Enanta Pharmaceuticals, IncLead Sponsor
39 Previous Clinical Trials
2,902 Total Patients Enrolled
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