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

December 12, 2021 updated by: Jeil Pharmaceutical Co., Ltd.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Gières, France, 38610
        • Recruiting
        • OPTIMED Clinical Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: JP-2266
Drug: JP-2266
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
PLACEBO_COMPARATOR: JP-2266 Placebo
Drug: JP-2266 Placebo
Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeil Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 24, 2020

Primary Completion (ANTICIPATED)

August 31, 2022

Study Completion (ANTICIPATED)

August 31, 2022

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

December 12, 2021

First Posted (ACTUAL)

December 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 12, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • JP-2266-101-FIH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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