Not Yet RecruitingPhase 1

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

South Korea48 participantsStarted 2025-04-21

Plain-language summary

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

Who can participate

Age range19 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 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

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

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

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

Trial details

NCT IDNCT06916130

SponsorAddpharma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-01

Contact for this trial

Hanna Yang

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

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