Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 in Healthy Subjects
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
1 other identifier
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus
Started Nov 2020
Typical duration for phase_1 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2020
CompletedFirst Submitted
Initial submission to the registry
November 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedDecember 29, 2021
December 1, 2021
1.8 years
November 1, 2021
December 12, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
The evaluation of the number of adverse events and the number and percentage of subjects
Single Ascending Dose
up to Day 10
Assessment of PK parameter: Maximum plasma concentration (Cmax)
Food effect cohort
up to 72hours of each period
The evaluation of the number of adverse events and the number and percentage of subjects
Multiple Ascending Dose
up to Day 19
Study Arms (2)
JP-2266
EXPERIMENTALDrug: JP-2266
JP-2266 Placebo
PLACEBO COMPARATORDrug: JP-2266 Placebo
Interventions
* 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
* 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
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- Any history (including family history) or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OPTIMED clinical research
Gières, 38610, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2021
First Posted
December 29, 2021
Study Start
November 24, 2020
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
December 29, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share