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

Sponsor
Jeil Pharmaceutical Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05172622
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
21.2
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 24, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The evaluation of the number of adverse events and the number and percentage of subjects [up to Day 10]

    Single Ascending Dose

  2. Assessment of PK parameter: Maximum plasma concentration (Cmax) [up to 72hours of each period]

    Food effect cohort

  3. The evaluation of the number of adverse events and the number and percentage of subjects [up to Day 19]

    Multiple Ascending Dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 OPTIMED clinical research Gières France 38610

Sponsors and Collaborators

  • Jeil Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05172622
Other Study ID Numbers:
  • JP-2266-101-FIH
First Posted:
Dec 29, 2021
Last Update Posted:
Dec 29, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 29, 2021