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

Phase 1

Not yet recruiting

• Conditions: Gastroesophageal Reflux Disease (GERD)
• Interventions: Drug: AD-120A; Drug: AD-120

• Registration Number: NCT06916130
• Lead Sponsor: Addpharma Inc.

Brief Summary

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

Detailed Description

The purpose of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety profiles of AD-120 compared with AD-120A in healthy subjects.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Study Start: 2025-04-21
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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

Exclusion Criteria

• Patients with trouble performing pH monitor catheter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm-A	AD-120A	Period 1 : Test Drug (AD-120), Period 2 : Reference Drug (AD-120A)
Arm-B	AD-120A	Period 1 : Reference Drug (AD-120A), Period 2 : Test Drug (AD-120)
Arm-B	AD-120	Period 1 : Reference Drug (AD-120A), Period 2 : Test Drug (AD-120)
Arm-A	AD-120	Period 1 : Test Drug (AD-120), Period 2 : Reference Drug (AD-120A)

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve over a dosing interval at steady state (AUCτ,ss)	AUCτ,ss: pre-dose to 24 hours of 1st administration versus pre-dose to 24 hours of repeated administration (7days)	AUCτ,ss after 7days repeated administration of Omeprazole
The time of peak concentration after single dose	Tmax: from pre-dose to 24 hours of 1st administration	Tmax after 1days administration of Omeprazole
Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring	24 hours before 1st administration to 24 hours after repeated administration (7days)	Percent decrease from baseline in integrated gastric acidity measured by 24h pH monitoring for 24-hour interval after 7th dose

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of