Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects

A Randomized, Open-label, Single-dose, 2x2 Crossover Study to Compare the Safety/Tolerability and Pharmacokinetics Between and DA-2803 and Vemlidy® After Meal in Healthy Adults

This study is an open-label, randomized, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Drug: Vemlidy Tab; Drug: DA-2803 Tab

Detailed Description

To healthy subjects of ninety-six (96), following treatments are administered dosing in each period and wash-out period is a minimum of 14 days.

Reference drug: Vemlidy Tab. / Test drug: DA-2803 Tab. Pharmacokinetic blood samples are collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 05505
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male volunteers, aged between ≥ 19 and ≤ 45 years old at the time of screening.

• Calculated body mass index (BMI) of ≥ 18.0 and ≤ 28.0 kg/m2

  • BMI = Weight(kg)/ Height(m)2
• Individuals who agreed proper contraception during the study and did consent to not donation of sperm and ovum before the termination of study
• Individuals who voluntary decide to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical trial

Exclusion Criteria:

• History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic, or psychiatric disorder.
• Any medical history that may affect drug absorption, distribution, metabolism and excretion.
• Individuals who had history of hypersensitivity to Investigational drugs, derivative drugs or others drugs(aspirin and antibiotics etc.)
• Any clinically significant chronic medical illness.
• Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

• Individuals with one of the following laboratory test results in screening.

  • AST, ALT > UNL (upper normal limit) x 1.5
  • Creatinine clearance ≤ 60 mL/min
  • Positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
• Use of any prescription drugs and herbal preparations within 14 days prior to study drug administration and use of over-the-counter medications within 10 days prior to study drug administration.
• Individuals who cannot eat standard meal provided from clinical trial center.
• Donation of blood within 60 days prior to study drug administration or apheresis within 30 days prior to the first IP administration.
• Individuals who had received a blood transfusion within 60 days prior to study drug administration.
• Exposure to any investigational drug within 6 months prior to the first IP administration.
• Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
• Individuals who had drinking (alcohol > 21unit/week) within 14 days prior to screening.
• Heavy smoking (more than 10 cigarettes/day) within 14 days prior to screening.
• Subjects having been deemed inappropriate for the trial as determined by the investigator.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reference-Test	Drug: Vemlidy Tab; 1T; Other Names: Reference; Drug: DA-2803 Tab; 1T; Other Names: Test
Experimental: Test-Reference	Drug: Vemlidy Tab; 1T; Other Names: Reference; Drug: DA-2803 Tab; 1T; Other Names: Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of DA-2803, Vemlidy	Area under the DA-2803/Vemlidy concentration in blood-time curve from zero to final	pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour
Cmax of DA-2803, Vemlidy	The maximum DA-2803/Vemlidy concentration in blood sampling time t	pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hour

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Actual): October 5, 2021
• Study Completion (Actual): October 5, 2021

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis; Hepatitis B
• Other Study ID Numbers: DA2803_BE_I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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