Comparing the effects of AD-227 and its combinations on healthy individuals
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of AD-227 Compared to Co-administration of AD-227A and AD-227B in Healthy Adult Volunteers Under Fasting Conditions
PHASE1 · Addpharma Inc. · NCT06884085
This study tests a new medication called AD-227 and its combinations with two other compounds in healthy volunteers to see how the body processes them and if they are safe.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Addpharma Inc. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06884085 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetic characteristics and safety profiles of a new medication, AD-227, in healthy volunteers. Participants will receive either AD-227 alone or in combination with two other compounds, AD-227A and AD-227B. The primary goal is to understand how these treatments are processed in the body and their safety. The study is designed for Phase 1, focusing on initial safety and pharmacokinetic data.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 19 and older with a body weight of at least 50 kg.
Not a fit: Patients who are currently participating in other clinical studies or have recently used investigational drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for managing primary hypertension.
How similar studies have performed: While this approach is common in pharmacokinetic studies, the specific combination of AD-227 and its components is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 another clinical study with an investigational drug within the 6 months from scheduled first administration * Other exclusions applied
Where this trial is running
Seoul
- Central Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: JeongEun Park
- Email: parkje@addpharma.co.kr
- Phone: +82-31-891-6989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Hypertension