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Status unknownNCT05172622Updated Dec 29, 2021

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

A Phase 1 interventional study of JP-2266 and JP-2266 Placebo in Diabetes Mellitus, sponsored by Jeil Pharmaceutical Co., Ltd.. Status unknown at 1 site in France. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-29.

Sponsored by Jeil Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Nov 2020, registered Nov 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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

Read the 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

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 80 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Jeil Pharmaceutical Co., Ltd. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

Exclusion Criteria:

  • Any history (including family history) or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    JP-2266

    Drug: JP-2266

    Drug: JP-2266

  • Placebo comparator
    JP-2266 Placebo

    Drug: JP-2266 Placebo

    Drug: JP-2266 Placebo

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. The evaluation of the number of adverse events and the number and percentage of subjects

    Single Ascending Dose

    Time frame: up to Day 10

  2. Assessment of PK parameter: Maximum plasma concentration (Cmax)

    Food effect cohort

    Time frame: up to 72hours of each period

  3. The evaluation of the number of adverse events and the number and percentage of subjects

    Multiple Ascending Dose

    Time frame: up to Day 19

07

Study locations

1 of 1 sites recruiting
  • OPTIMED clinical research
    Gières, 38610, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05172622
Lead sponsor
Jeil Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 29, 2021
Start date
Nov 24, 2020
Primary completion
Aug 31, 2022 (estimated)
Completion
Aug 31, 2022 (estimated)
Last update
Dec 29, 2021

Study contacts

Yves DONAZZOLO, MD, MSc,
Contact
YvesDonazzolo@eurofins.com
33-438-372-747

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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