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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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05172622
Enrollment
80
Registered
2021-12-29
Start date
2020-11-24
Completion date
2022-08-31
Last updated
2021-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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

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

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

Sponsors

Jeil Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
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;

Design outcomes

Primary

MeasureTime frameDescription
The evaluation of the number of adverse events and the number and percentage of subjectsup to Day 10Single Ascending Dose
Assessment of PK parameter: Maximum plasma concentration (Cmax)up to 72hours of each periodFood effect cohort

Countries

France

Contacts

Primary ContactYves DONAZZOLO, MD, MSc,
YvesDonazzolo@eurofins.com33-438-372-747

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026