Phase 1 study of EA3355 in Japanese and Caucasian healthy adult subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225068

Enrollment

200

Registered

2020-02-13

Start date

2020-02-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult subjects

Interventions

investigational material(s) Generic name etc : EA3355 INN of investigational material : - Therapeutic category code : 391 Agents for liver disease Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. A Japanese or Caucasian healthy adult aged between 20 and 44 inclusive at the time of written informed consent 2. A BMI meeting the following criterion at screening Japanese subjects,>= 18.5 and = 18.5 and < 30.0 kg/m2 3. Non-smoker or someone able to abstain from smoking between 6 months before investigational product administration and the follow-up examination 4. Consenting in writing to participate in this clinical study on his/her own free will and able to comply with the requirements in the clinical study

Exclusion criteria

Exclusion criteria: (1) Surgical history at screening that affects the PK of the investigational product. (2) History or complication at screening or any physical finding, vital sign, ECG finding, or laboratory value at screening or baseline that raises suspicion of a clinically abnormal symptom or organ dysfunction that requires treatment. (3) History of allergy to any drugs at screening. (4) Use of prescription drugs or over-the-counter drugs within 4 weeks before the investigational product administration. (5) Treatment with EA3355 in this clinical study, ongoing participation in another clinical study, or use of an investigational product or device while participating in another clinical study within 16 weeks before giving consent. (6) Women who are nursing or pregnant at screening or baseline. (7) Anyone deemed ineligible to participate in this clinical study by the investigator or sub investigator.

Design outcomes

Primary

Measure	Time frame
safety pharmacokinetics - AEs - Laboratory tests - Vital signs - 12-lead ECGs - Physical findings - Plasma EA3355 concentrations - Urinary EA3355 excretions - PK parameters	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026