Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, 66219, United States
NCT Number: NCT05246878
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Lenexa, Kansas, 66219, United States
The first phase assesses single ascending doses of EDP-235 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses of EDP-235 or placebo for 7-days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-235 or placebo.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral administration
Placebo to match EDP-235, oral administration
Time frame: Up to 8 Days in HV SAD Cohorts
Time frame: Up to 14 Days in HV MAD Cohorts
Time frame: Up to 5 Days in HV SAD Cohorts
Time frame: Up to 5 Days in HV SAD Cohorts
Time frame: Up to 11 Days in HV MAD Cohorts
Time frame: Up to 11 Days in HV MAD Cohorts
Enanta Pharmaceuticals, Inc
Industry
A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First In Human Study of Orally Administered EDP-235 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-235 Pharmacokinetics in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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