Clinical Trials Directory

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UnknownNCT05172622

Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 in Healthy Subjects

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

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Jeil Pharmaceutical Co., Ltd. · Industry
Sex
Male
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DRUGJP-2266* Single Ascending Dose: Single administration on Day 1 * Food effect cohort: Single administration on Day 1 of each period * Multiple Ascending Dose: Repeated administrations from D1 to D15
DRUGJP-2266 Placebo* Single Ascending Dose: Single administration on Day 1 * Food effect cohort: Single administration on Day 1 of each period * Multiple Ascending Dose: Repeated administrations from D1 to D15

Timeline

Start date
2020-11-24
Primary completion
2022-08-31
Completion
2022-08-31
First posted
2021-12-29
Last updated
2021-12-29

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05172622. Inclusion in this directory is not an endorsement.