To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901

An Open-label, Randomized, Single Administration, Full Replicated Crossover Phase 1 Clinical Trial to Compare Pharmacokinetics and Safety Between JLP-1901 and JC-001 in Healthy Subjects

To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901

Study Overview

• Status: Completed
• Conditions: Healthy Adult
• Intervention / Treatment: Drug: JLP-1901; Drug: JC-001(active comparator)

Detailed Description

An open-label, randomized, single administration, full replicated crossover phase 1 clinical trial to compare pharmacokinetics and safety between JLP-1901 and JC-001 in healthy subjects

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang-gu
    • Gyeonggi-do, Bundang-gu, Korea, Republic of, 13497
      • Bundang CHA university global clinical trials center Institutional Review Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adults over 19 years of age and under 65 years of age at the time of screening test
2. Those with a body mass index (BMI) of 17.5 kg/m2 or more but less than 30.5 kg/m2 and a body weight of 55 kg or more for men and 45 kg or more for women.
3. Those who do not have congenital or chronic diseases within the past 3 years and have no pathological symptoms or findings as a result of internal medical examination
4. Subjects determined to be suitable as a trial subject as a result of tests performed during screening, such as laboratory tests (hematology test, blood chemistry test, urinalysis, virus/bacteria test, etc.) conducted by the investigator according to the characteristics of the drug, vital signs, and electrocardiogram test.

Exclusion Criteria:

1. Those who have history or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, nervous or immune diseases (excluding simple dental history such as calculus, impacted teeth, wisdom teeth, etc.)
2. Those whd have a history of gastrointestinal disease (esophageal disease such as achalasia or esophageal stricture, Crohn's disease) or surgery (excluding simple appendectomy, hernia surgery, or tooth extraction surgery) that may affect drug absorption ruler

3. A subject who shows the following values as a result of a laboratory test:

   ☞ ALT or AST > 2 times the upper limit of normal range

4. Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months of screening (1 glass (250 mL) of beer (5%) = 10 g, 1 glass (50 mL) of soju (20%) = 8 g , 1 glass of wine (12%) (125 mL) = 12 g)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment(Experimental): JLP-1901; Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008])	Drug: JLP-1901; administration of JLP-1901; Other Names: anti-viral; Drug: JC-001(active comparator); administration of JC-001(tenofovir); Other Names: tenofovir
Active Comparator: Control(Active Comparator): JC-001; Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008])	Drug: JLP-1901; administration of JLP-1901; Other Names: anti-viral; Drug: JC-001(active comparator); administration of JC-001(tenofovir); Other Names: tenofovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC over 24H of JLP-1901	AUC over 24H	24 hours
Cmax of JLP-1901	Cmax	24 hours

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): May 13, 2022

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: JP-1901-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No