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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172622
• Other study ID #: JP-2266-101-FIH
• Status: Recruiting
• Phase: Phase 1
• Start date: November 24, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: December 2021
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: Yves DONAZZOLO, MD, MSc,
• Phone: 33-438-372-747
• Email: YvesDonazzolo[@]eurofins.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• JP-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
• JP-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

Locations

Country	Name	City	State
France	OPTIMED clinical research	Gières

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of the number of adverse events and the number and percentage of subjects	Single Ascending Dose	up to Day 10
Primary	Assessment of PK parameter: Maximum plasma concentration (Cmax)	Food effect cohort	up to 72hours of each period
Primary	The evaluation of the number of adverse events and the number and percentage of subjects	Multiple Ascending Dose	up to Day 19