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

NCT ID: NCT05172622

Last Updated: 2021-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-24

Study Completion Date

2022-08-31

Brief Summary

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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

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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

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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JP-2266

Drug: JP-2266

Group Type EXPERIMENTAL

JP-2266

Intervention Type DRUG

* 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

Drug: JP-2266 Placebo

Group Type PLACEBO_COMPARATOR

JP-2266 Placebo

Intervention Type DRUG

* 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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OPTIMED clinical research

Gières, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Yves DONAZZOLO, MD, MSc,

Role: CONTACT

Phone: 33-438-372-747

Email: [email protected]

Facility Contacts

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Yves Donazzolo, MD, MSc

Role: primary

Other Identifiers

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JP-2266-101-FIH

Identifier Type: -

Identifier Source: org_study_id