Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 in Healthy Subjects
- Registration Number
- NCT05172622
- Lead Sponsor
- Jeil Pharmaceutical Co., Ltd.
- Brief Summary
Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects
- Detailed Description
A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 80
Inclusion Criteria
- Healthy male Caucasian subject aged 18 to 50 years inclusive
- Body Mass Index (BMI) between 18 and 27 kg/m2 inclusive and body weight ≥ 50 kg at screening
- Signing a written informed consent prior to selection;
Exclusion Criteria
- Any history (including family history) or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JP-2266 JP-2266 Drug: JP-2266 JP-2266 Placebo JP-2266 Placebo Drug: JP-2266 Placebo
- Primary Outcome Measures
Name Time Method Assessment of PK parameter: Maximum plasma concentration (Cmax) up to 72hours of each period Food effect cohort
The evaluation of the number of adverse events and the number and percentage of subjects up to Day 19 Multiple Ascending Dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
OPTIMED clinical research
🇫🇷Gières, France