A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEnanta Pharmaceuticals, Inc

About this trial

This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

An informed consent document signed and dated by the subject.

Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.

Disqualifiers

Clinically relevant evidence or history of illness or disease.

Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit

Pregnant or nursing females.

History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EDP-978

    Drug

    Oral administration

  • Placebo

    Drug

    Placebo to match EDP-978, oral administration

Treatment groups

98 Participants
are divided into 4 treatment groups
Group A: EDP-978 SAD CohortsExperimental treatment 1 intervention
Group B: EDP-978 MAD CohortsExperimental treatment 1 intervention
Group C: EDP-978 SAD Placebo CohortsPlacebo comparator 1 intervention
Group D: EDP-978 MAD Placebo CohortsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety measured by adverse events

Time frame
Up to 8 Days in SAD Cohorts
2

Safety measured by adverse events

Time frame
Up to 28 Days in MAD Cohorts

Secondary outcomes

1

Cmax of EDP-978

Time frame
Up to 5 Days in SAD Cohorts
2

AUC of EDP-978

Time frame
Up to 5 Days in SAD Cohorts
3

Cmax of EDP-978

Time frame
Up to 18 Days in MAD Cohorts
4

AUC of EDP-978

Time frame
Up to 18 Days in MAD Cohorts

Other outcomes

Sponsors and contacts

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