Phase 1 study of EA3355 in Japanese and Caucasian healthy adult subjects
- Conditions
- Healthy adult subjects
- Registration Number
- JPRN-jRCT2080225068
- Lead Sponsor
- EA Pharma Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 200
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 < 25.0 kg/m2
Caucasian subjects, >= 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
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br><Safety><br>- AEs<br>- Laboratory tests<br>- Vital signs<br>- 12-lead ECGs<br>- Physical findings<br><Pharmacokinetics><br>- Plasma EA3355 concentrations<br>- Urinary EA3355 excretions <br>- PK parameters
- Secondary Outcome Measures
Name Time Method