RecruitingPhase 1

A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284

South Korea60 participantsStarted 2025-03-10

Plain-language summary

Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects.

Who can participate

Age range19 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 50kg (Female 45kg) and Body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * The Age equal to or greater than 19 in healthy volunteers at the time of screening visit Exclusion Criteria: * Participation in other clinical study with an investigational drug within the 6 months from scheduled first administration * Other exclusions applied

What they're measuring

Maximum concentration of drug in plasma (Cmax)

Timeframe: pre-dose (0hour) to 72hours

Area under the plasma concentration-time curve during dosing interval (AUCt)

Timeframe: pre-dose (0hour) to 72hours

Trial details

NCT IDNCT06884098

SponsorAddpharma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04

Contact for this trial

JeongEun Park

+82-31-891-6989 parkje@addpharma.co.kr

View on ClinicalTrials.gov More Primary Hypercholesterolaemia trials