MalariaPhase 1NCT06854042
A Study of Oral E1018 in Healthy Adult Participants
A Phase 1 study testing E1018 in people with Malaria and Healthy Participants, run by Eisai Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Healthy Participants
- What is being tested?
- E1018
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2025to 22 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Body Mass Index (BMI) >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at Screening.
Who cannot join
- 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.
- 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).
- 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
Show all 23Show fewer
- 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.
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
- Presence of concurrent febrile illness(es) at Screening or Baseline.
- Any history of surgery that may affect PK profiles of E1018 (example, hepatectomy, nephrectomy, digestive organ resection) or participants who have a congenital abnormality in metabolism at Screening.
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, ECG finding, or laboratory test results that require medical treatment at Screening or Baseline.
- Left bundle branch block.
- History of myocardial infarction, active ischemic heart disease, or clinically significant or uncontrolled arrhythmia.
- Known history of clinically significant drug allergy at Screening.
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening.
- Known to be human immunodeficiency virus (HIV)-positive at Screening.
- Active viral hepatitis (A, B or C) as demonstrated by positive serology at Screening.
- History of drug or alcohol dependency or abuse, or those who have a positive urine drug test or breath alcohol test at Screening or Baseline.
- Currently enrolled in another clinical study or used any investigational drug or device within 30 days or 5 half-lives (whichever is longer) preceding informed consent.
- Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week of dosing.
- A history of noncompliance in any previous study or inability to comply with study conduct, as assessed by the investigator.
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Malaria, Healthy Participants
- Being tested
- E1018, Placebo
- Keywords
- E1018
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E1018Drug
Specified dose on specified days.
PlaceboDrug
E1018 matching placebo on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: E1018 or Placebo | Experimental | Not described Receives: Drug: E1018; Drug: Placebo |
| Cohort 2: E1018 or Placebo | Experimental | Not described Receives: Drug: E1018; Drug: Placebo |
| Cohort 3: E1018 or Placebo | Experimental | Not described Receives: Drug: E1018; Drug: Placebo |
| Cohort 4: E1018 or Placebo | Experimental | Not described Receives: Drug: E1018; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-limiting Events
Measured: Up to Day 20
Number of Participants With Adverse Events (Serious and Non-serious)
Measured: Up to Day 20
Number of Participants With Clinically Significant Laboratory Test Results
Measured: Up to Day 20
Number of Participants With Clinically Significant Vital Signs Values
Measured: Up to Day 20
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Measured: Up to Day 20
AUC(0-t): Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for E1018
Measured: Up to Day 20
AUC(0-inf): Area Under the Concentration-time Curve From Zero Time Extrapolated to Infinite Time for E1018
Measured: Up to Day 20
Cmax: Maximum Observed Concentration for E1018
Measured: Up to Day 20
Tmax: Time at Which the Highest Drug Concentration Occurs for E1018
Measured: Up to Day 20
t½: Terminal Elimination Phase Half-life for E1018
Measured: Up to Day 20
CL/F: Apparent Total Clearance Following Oral Administration for E1018
Measured: Up to Day 20
Vz/F: Apparent Volume of Distribution at Terminal Phase for E1018
Measured: Up to Day 20
Ae: Cumulative Amount of E1018 Excreted in the Urine
Measured: Up to Day 6
Fe: Percent (%) of Administered E1018 Dose Excreted in Urine
Measured: Up to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start26 Feb 2025
- Primary completion22 Jul 2027 (estimated)
- Study completion22 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854042
- Sponsor's protocol ID
- E1018-G000-001
- Other IDs
- CDMRPPR210253-A
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06854042
- Acronym / sponsor ID
- E1018-G000-001
- Conditions
- Malaria, Healthy Participants
- Keywords
- E1018
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 22 Jul 2027 (estimated)
- Study completion
- 22 Jul 2027 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: E1018 or Placebo | Experimental | Drug: E1018, Drug: Placebo |
| Cohort 2: E1018 or Placebo | Experimental | Drug: E1018, Drug: Placebo |
| Cohort 3: E1018 or Placebo | Experimental | Drug: E1018, Drug: Placebo |
| Cohort 4: E1018 or Placebo | Experimental | Drug: E1018, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
- Body Mass Index (BMI) >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at Screening.
Key exclusion criteria (23 listed)
- 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.
- 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).
- 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.
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
- Presence of concurrent febrile illness(es) at Screening or Baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E1018Specified dose on specified days. | Drug | Cohort 1: E1018 or Placebo, Cohort 2: E1018 or Placebo, Cohort 3: E1018 or Placebo, Cohort 4: E1018 or Placebo |
| PlaceboE1018 matching placebo on specified days. | Drug | Cohort 1: E1018 or Placebo, Cohort 2: E1018 or Placebo, Cohort 3: E1018 or Placebo, Cohort 4: E1018 or Placebo |
Primary outcome
Number of Participants With Dose-limiting Events
Time frame: Up to Day 20
Number of Participants With Adverse Events (Serious and Non-serious)
Time frame: Up to Day 20
Number of Participants With Clinically Significant Laboratory Test Results
Time frame: Up to Day 20
Number of Participants With Clinically Significant Vital Signs Values
Time frame: Up to Day 20
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
Time frame: Up to Day 20
AUC(0-t): Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for E1018
Time frame: Up to Day 20
AUC(0-inf): Area Under the Concentration-time Curve From Zero Time Extrapolated to Infinite Time for E1018
Time frame: Up to Day 20
Cmax: Maximum Observed Concentration for E1018
Time frame: Up to Day 20
Tmax: Time at Which the Highest Drug Concentration Occurs for E1018
Time frame: Up to Day 20
t½: Terminal Elimination Phase Half-life for E1018
Time frame: Up to Day 20
CL/F: Apparent Total Clearance Following Oral Administration for E1018
Time frame: Up to Day 20
Vz/F: Apparent Volume of Distribution at Terminal Phase for E1018
Time frame: Up to Day 20
Ae: Cumulative Amount of E1018 Excreted in the Urine
Time frame: Up to Day 6
Fe: Percent (%) of Administered E1018 Dose Excreted in Urine
Time frame: Up to Day 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E1018 in people with Malaria and Healthy Participants, run by Eisai Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-limiting Events (time frame: Up to Day 20). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.