A Study to Evaluate the Safety and Pharmacokinetics of AD-228A Compared to Coadministration of AD-2281 and AD-2282
Phase 1
Not yet recruiting
- Conditions
- Primary Hypercholesterolaemia
- Interventions
- Drug: AD-228ADrug: AD-2281 and AD-2282
- Registration Number
- NCT06858865
- Lead Sponsor
- Addpharma Inc.
- Brief Summary
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228A in healthy subjects.
- Detailed Description
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety profiles of AD-228A compared with coadministration AD-2281 and AD-2282 in healthy subjects.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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 another clinical study with an investigational drug within the 6 months from scheduled first administration
- Other exclusions applied
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A AD-228A Period 1 : Reference Drug(AD-2281 and AD-2282), Period 2 : Test Drug(AD-228A) Sequence A AD-2281 and AD-2282 Period 1 : Reference Drug(AD-2281 and AD-2282), Period 2 : Test Drug(AD-228A) Sequence B AD-228A Period 1 : Test Drug(AD-228A), Period 2 : Reference Drug(AD-2281 and AD-2282) Sequence B AD-2281 and AD-2282 Period 1 : Test Drug(AD-228A), Period 2 : Reference Drug(AD-2281 and AD-2282)
- Primary Outcome Measures
Name Time Method Maximum concentration of drug in plasma (Cmax) pre-dose to 72 hours Cmax of AD-228A
Area under the plasma concentration-time curve during dosing interval (AUCt) pre-dose to 72 hours AUCt of AD-228A
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular targets does AD-228A modulate compared to AD-2281 and AD-2282 in primary hypercholesterolemia?
How does AD-228A's LDL-C reduction efficacy compare to statins and PCSK9 inhibitors in primary hypercholesterolemia patients?
Which biomarkers correlate with pharmacokinetic response to AD-228A in primary hypercholesterolemia?
What safety profiles and adverse event management strategies are observed for AD-228A versus AD-2281/AD-2282 coadministration in healthy adults?
What PCSK9 inhibitor combinations or dual-action therapies are in development for familial hypercholesterolemia, and how do they compare to Addpharma's AD-228A?
Trial Locations
- Locations (1)
H+ Yangji Hospital
🇰🇷Seoul, Korea, Republic of