Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06170242
Other study ID # EDP 323-101
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 20, 2023
Est. completion date June 2024

Study information

Verified date November 2023
Source Enanta Pharmaceuticals, Inc
Contact Enanta Pharmaceuticals, Inc
Phone (617) 607-0800
Email jdevincenzo@enanta.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-323 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to assess the antiviral effect of EDP-323 compared to a placebo control in the respiratory syncytial virus challenge model.


Recruitment information / eligibility

Status Recruiting
Enrollment 114
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - An informed consent document signed and dated by the subject. - Age 18 to 55 years, inclusive. - In good health with no history of major medical conditions. - A total body weight = 50 kg and Body Mass Index (BMI) = 18 kg/m2 and = 35kg/m2. Exclusion Criteria: - Pregnant or nursing females - Acute or chronic medical illness - History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT or LRT) infection within 4 weeks prior to the first study visit. - Abnormal lung function - Positive for HIV, active hepatitis B or C test - Nose or nasopharynx abnormalities - Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
EDP-323 Dose Regimen 1
EDP-323 capsule
EDP-323 Dose Regimen 2
EDP-323 capsule
Placebo
Placebo capsule

Locations

Country Name City State
United Kingdom hVIVO Services Limited London

Sponsors (2)

Lead Sponsor Collaborator
Enanta Pharmaceuticals, Inc hVIVO Services Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in viral load measurements Area under the curve for RSV viral load as measured by RT-qPCR assay from the first viral load measurement post initial dose of EDP-323 or placebo through day 12 Post initial dose of EDP-323 up to Day 12
Secondary Change in Total Symptom Score (TSS) Area Under the Curve (AUC) of TSS through Day 12 Innoculation through Day 12
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03698084 - RESCEU: Defining the Burden of RSV Disease
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05587478 - A Study of EDP-323 in Healthy Subjects Phase 1
Recruiting NCT06180993 - Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
Suspended NCT03909867 - Emission Patterns of Respiratory Syncytial Virus
Recruiting NCT06259487 - Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis. N/A
Not yet recruiting NCT04144816 - Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants
Completed NCT01090557 - Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study N/A
Terminated NCT01475305 - Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV) Phase 1
Not yet recruiting NCT05928507 - FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
Completed NCT03062917 - Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis N/A
Completed NCT03691623 - A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model Phase 2
Completed NCT03387137 - Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children Phase 1
Completed NCT05070975 - Severity of RSV Infections in Twins
Active, not recruiting NCT04938830 - Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) Phase 3
Recruiting NCT05568706 - A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications. Phase 2
Completed NCT03755778 - Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects Phase 1
Completed NCT01483911 - ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers Phase 1
Completed NCT03750383 - Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects Phase 1
Completed NCT05118386 - Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults Phase 1