A Study to Compare PK/PD Characteristics and Safety Profiles Between AD-120 and AD-120A

NCT06916130 | Not Yet Recruiting Phase 1

• 1 other identifier: AD-120PK/PD
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.

Conditions

Gastroesophageal Reflux Disease (GERD)

Outcome Measures

Primary Outcomes (3)

• Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)

  AUCτ,ss after 7days repeated administration of Omeprazole

  AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)

• The time of peak concentration after single dose

  Tmax after 1days administration of Omeprazole

  Tmax: from pre-dose to 24 hours of 1st administration

• Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring

  Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring for 24-hour interval after 7th dose

  24 hours before 1st administration to 24 hours after repeated administration (7days)

Study Arms (2)

Arm-A

EXPERIMENTAL

Period 1 : Test Drug (AD-120), Period 2 : Reference Drug (AD-120A)

Drug: AD-120A; Drug: AD-120

Arm-B

EXPERIMENTAL

Period 1 : Reference Drug (AD-120A), Period 2 : Test Drug (AD-120)

Drug: AD-120A; Drug: AD-120

Interventions

AD-120A DRUG

Administered before the breakfast during 7 days, Oral, Tablet

Also known as: Reference Drug

Arm-A; Arm-B

AD-120 DRUG

Administered before the breakfast during 7 days, Oral, Tablet

Also known as: Test drug

Arm-A; Arm-B

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight equal to or greater than 50.0kg and equal to or less than 90.0kg and Body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at the time of screening visit
• The Age equal to or greater than 19 and equal to or less than 50 in healthy volunteers at the time of screening visit
• Negative result from Serum Helicobacter pylori antibody at the time of screening visit

You may not qualify if:

• Patients with trouble performing pH monitor catheter

Sponsors & Collaborators

• Addpharma Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Central Study Contacts

Hanna Yang

CONTACT

+82-31-891-6918; hnyang@addpharma.co.kr

Seung Hwan Lee, M.D., Ph.D.

CONTACT

Study Design

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

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 8, 2025
• Study Start: April 21, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-03

Locations

KR (1)