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A Study of Oral E1018 in Healthy Adult Participants | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study of Oral E1018 in Healthy Adult Participants

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

NCT06854042•Eisai Inc.

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to evaluate the safety and tolerability of single ascending oral doses of E1018 in healthy adult participants and to evaluate the pharmacokinetics (PK) of E1018 in plasma and urine after single oral dose administration.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Nonsmoking/vaping, male or female, age greater than or equal to (\>=) 18 years to less than or equal (\<=) 55 years old at the time of informed consent. To be considered nonsmokers, participant must have discontinued smoking/vaping for at least 4 weeks before dosing.
•2. Body Mass Index (BMI) \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening.

Exclusion Criteria

•1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[β-hCG\] (or human chorionic gonadotropin \[hCG\]) test with a minimum sensitivity of 25 international units per liter (IU/L) or equivalent units of β-hCG \[or hCG\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the dose of study drug.
•2. Females of childbearing potential. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing).
•3. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method, as described below, throughout the study period and for 28 days after study drug discontinuation. If the female partner is pregnant, then males who do not agree to use latex or synthetic condoms throughout the study period and for 28 days after study drug discontinuation. No sperm donation is allowed during the study period and for 28 days after study drug discontinuation. The duration may be expanded further based on the half-life of the study drug calculated in this study.
•• A highly effective method of contraception includes any of the following:
•* total abstinence (if it is their preferred and usual lifestyle)
•* an intrauterine device or intrauterine hormone-releasing system
•* a contraceptive implant
•* an oral contraceptive (the participant's partner must have been on a stable dose of the same oral contraceptive product for at least 28 days before dosing and must agree to stay on the same dose of oral contraceptive throughout the study and for 28 days after study drug discontinuation). It is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant's partner, then the participant must agree to use a medically acceptable method of contraception, that is, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide. The duration of contraception period may be extended based on the half-life of the study drug calculated in this study.
•4. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
•5. Presence of concurrent febrile illness(es) at Screening or Baseline.
+13 more criteria

Locations (1)

PPD Development, LP

Austin, Texas, United States

Key Dates

Start Date

February 26, 2025

Primary Completion Date

December 23, 2025

Completion Date

December 23, 2025

Last Updated

September 24, 2025

Enrollment

ESTIMATED participants

Conditions

MalariaHealthy Participants

Interventions

E1018

DRUG

Placebo

DRUG

Contacts

Eisai Medical Information

CONTACT

+1-888-274-2378 esi_medinfo@eisai.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Oral E1018 in Healthy Adult Participants

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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