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

Jeil Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: JP-2266; Drug: JP-2266 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05172622

JP-2266-101-FIH

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

JP-2266

Experimental group

Description:

Drug: JP-2266

Treatment:

Drug: JP-2266

JP-2266 Placebo

Placebo Comparator group

Description:

Drug: JP-2266 Placebo

Treatment:

Drug: JP-2266 Placebo