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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days in mad cohorts for reporting.

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

Do I qualify?Apply below to find out

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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

Frequently Asked Questions

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

What is the approximate enrolment figure for this clinical experiment?

"Affirmative, according to the clinicaltrials.gov portal this medical trial is actively recruiting patients. The experiment was originally advertised on September 29th 2022 and has been updated most recently on October 17th 2022; 82 participants are anticipated at one centre."

Answered by AI

Is it possible for new participants to join the current experiment?

"According to clinicaltrials.gov, this trial is actively searching for participants who meet the eligibility criteria. Originally posted on September 29th 2022 and recently updated on October 17th 2022, it seeks suitable candidates in order to proceed with data collection."

Answered by AI

Are individuals aged 35 and over considered to be qualified participants of this research?

"For this study, participants must meet the age criteria of being over 18 years old and under 65."

Answered by AI

Could I be considered as a participant in this research project?

"This clinical trial is actively seeking 82 volunteers suffering from respiratory syncytial virus between the ages of 18 and 65. To qualify, participants must provide a signed informed consent document in addition to meeting other requirements such as being healthy males or females of any ethnic origin aged between 18-65."

Answered by AI

Has the EDP-323 SAD Cohorts obtained regulatory authorization?

"Considering the early stage of testing, we assign a safety score of 1 to EDP-323 SAD Cohorts due to a lack of substantial evidence regarding their efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of EDP-323 in Healthy Subjects

2022. "A Study of EDP-323 in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05587478.