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 of JP-2266 in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Assessment of PK parameter: Maximum plasma concentration (Cmax)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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;
Arms & Interventions
JP-2266
Drug: JP-2266
Intervention: JP-2266 (Drug)
JP-2266 Placebo
Drug: JP-2266 Placebo
Intervention: JP-2266 Placebo (Drug)
Outcomes
Primary Outcomes
Assessment of PK parameter: Maximum plasma concentration (Cmax)
Time Frame: up to 72hours of each period
Food effect cohort
The evaluation of the number of adverse events and the number and percentage of subjects
Time Frame: up to Day 19
Multiple Ascending Dose
Secondary Outcomes
No secondary outcomes reported