Phase 1 study of EA3571 in healthy adult subjects

JRCT ID: jRCT2051220036

Registered date:28/05/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Nonalcoholic Steatohepatitis
• Date of first enrollment: 14/06/2022
• Target sample size: 163
• Study type: Interventional
• Intervention(s): Single or multiple oral doses of EA3571 or placebo

Outcome(s)

Primary Outcome

Safety: AEs, Laboratory tests, Vital signs, Body weight, 12-lead ECGs, Physical findings
Pharmacokinetics: Plasma EA3571 concentrations, Urinary EA3571 excretions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Male

Include 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 < 25.0 kg/m2
Caucasian subjects, >= 18.5 and < 30.0 kg/m2
3. 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

Exclude 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 gelatin, other foods, or any drugs at screening
4. Use of prescription drugs or over-the-counter drugs within 4 weeks before the investigational product administration
5. 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. Anyone deemed ineligible to participate in this clinical study by the investigator or sub investigator

Related Information

• Primary Sponsor: Takeuchi Yutaka