A First-In-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral E1018 in Healthy Adult Subjects

Eisai Clinical Trials

Protocol # E1018-G000-001

Study Overview

Study Compound: E1018

Drug Name:

Registry #: NCT06854042, CDMRPPR210253-A

Trial Period: Feb 2025 -

Indication: Malaria

Primary Endpoint: 1. Number of Participants With Dose-limiting Events [Time Frame: Up to Day 20]
2. Number of Participants With Adverse Events (Serious and Non-serious) [Time Frame: Up to Day 20]
3. Number of Participants With Clinically Significant Laboratory Test Results [Time Frame: Up to Day 20]

Population
Males and females 18 Years to 55 Years (Adult)
Study Status
Ongoing
Study Phase
Phase 1
Countries
United States

Clinical Trial Documents

Clinical Study Report Synopsis

No download available

Plain Language Protocol Synopsis (PLPS)

Download PDF

Plain Language Summary of Results (PLS)

No download available

Publication reference citation

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is not available for this study.

CSDR	Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type	Availability
Protocol
SAP
Sample CRF
Full CSR