臨床研究等提出・公開システム

A Phase 1 Study of EA8001 in Healthy Adult Subjects

A Phase 1 Study of EA8001 in Healthy Adult Subjects

Chihiro Saito

EA Pharma Co., Ltd

2-1-1, Irifune, Chuo-ku, Tokyo

contact_ea@eapharma.co.jp

Chihiro Saito

EA Pharma Co., Ltd

2-1-1, Irifune, Chuo-ku, Tokyo

+81-3-6280-9600

contact_ea@eapharma.co.jp

Pending

June. 01, 2026

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

1.Male or female Japanese healthy adult subjects aged 18 years or more and less than 45 years at the time of informed consent
2.Subjects with a BMI at screening of >=17.0 kg/m2 and <30.0 kg/m2
3.Subjects who voluntarily provide written informed consent to participate in this study and are able to comply with the study requirements

1. Subjects with a history of clinically significant disease requiring treatment within 8 weeks before assignment to the study intervention, or a history of clinically significant infection within 4 weeks before assignment to the study intervention, or subjects who are scheduled to undergo surgery requiring general anesthesia, spinal anesthesia, or epidural anesthesia during the study
2. Subjects with a history of surgical treatment at screening that may affect the evaluation of this study (e.g., resection of the liver, kidney, or gastrointestinal tract)
3. Subjects who are suspected of having clinically abnormal symptoms requiring treatment or organ dysfunction on the basis of medical history/concomitant diseases, physical findings, vital signs, standard 12-lead electrocardiogram, or clinical laboratory test values at screening or eligibility assessment
4. Subjects with a history of drug or alcohol dependence or abuse within 2 years, or with a positive urine drug screen or alcohol test
5. Subjects who test positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or syphilis
6. Subjects who are currently participating in another clinical trial, or who participated in another clinical trial and received an investigational drug or used an investigational medical device within 16 weeks before informed consent
7. Subjects who are pregnant or breastfeeding, have a positive pregnancy test, or do not agree to use the required contraception

Both

Schizophrenia

Part 1
Twenty-four subjects will be assigned to 3 cohorts (8 subjects per cohort: Cohort 1-1, EA8001 15 mg; Cohort 1-2, EA8001 30 mg; Cohort 1-3, EA8001 60 mg), and EA8001 will be administered as a single oral dose under fasted conditions.
In Cohort 1-2, following a single oral dose of EA8001 30 mg under fasted conditions, a single oral dose of 30 mg will be administered under fed conditions, followed by repeated oral dosing of 30 mg under fed conditions.

Part 2
Up to 3 subjects will receive EA8001 as single oral doses under fasted conditions with dose escalation within the same subject in the order of 15 mg, 30 mg, and 60 mg.

Plasma concentrations of EA8001 and 3-BPAA
Pharmacokinetic parameters

No

none