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

NCT06171880 | Completed Phase 1

• 1 other identifier: JP-1901-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (2)

• AUC over 24H of JLP-1901

  AUC over 24H

  24 hours

• Cmax of JLP-1901

  Cmax

  24 hours

Study Arms (2)

Treatment(Experimental): JLP-1901

EXPERIMENTAL

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; Drug: JC-001(active comparator)

Control(Active Comparator): JC-001

ACTIVE COMPARATOR

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; Drug: JC-001(active comparator)

Interventions

JLP-1901 DRUG

administration of JLP-1901

Also known as: anti-viral

Control(Active Comparator): JC-001; Treatment(Experimental): JLP-1901

JC-001(active comparator) DRUG

administration of JC-001(tenofovir)

Also known as: tenofovir

Control(Active Comparator): JC-001; Treatment(Experimental): JLP-1901

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults over 19 years of age and under 65 years of age at the time of screening test
• 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.
• 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
• 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.

You may not qualify if:

• 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.)
• 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
• 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
• 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)

Sponsors & Collaborators

• Jeil Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Bundang CHA university global clinical trials center Institutional Review Board

Gyeonggi-do, Bundang-gu, 13497, South Korea

Location

MeSH Terms

Interventions

Tenofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 15, 2023
• Study Start: February 15, 2022
• Primary Completion: March 11, 2022
• Study Completion: May 13, 2022
• Last Updated: December 15, 2023

Record last verified: 2023-11

Locations

KR (1)