Safety and how the body handles AD-116 and AD-1161 in healthy adult men
An Open-Label, Randomized, Single-Dose, Two-Sequence, Two-Period Crossover Clinical Trial to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Volunteers Under Fed Conditions
This will test how safe AD-116 and AD-1161 are and how the body processes them in healthy adult men after a meal.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 19 Years and up |
| Sex | Male |
| Sponsor | Addpharma Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07444385 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial tests the safety and pharmacokinetics of two experimental drugs, AD-116 and AD-1161, when given under fed conditions to healthy adult male volunteers. Participants must be male, at least 19 years old, weigh at least 50 kg, and have a BMI between 18.0 and 30.0 kg/m2. The study is conducted at H PLUS YANGJI HOSPITAL in Seoul and excludes volunteers who have received another investigational drug within six months or meet other exclusion criteria. Researchers will collect safety data and blood samples over a defined dosing and sampling schedule to measure drug concentrations and monitor adverse events.
Who should consider this trial
Good fit: Ideal candidates are healthy adult men aged 19 or older who weigh at least 50 kg, have a BMI of 18.0–30.0 kg/m2, and are not participating in other investigational drug studies.
Not a fit: People who are under 19, have significant health problems, fall outside the weight/BMI ranges, or are currently in other investigational drug trials may not benefit from participating.
Why it matters
Potential benefit: If successful, the results could identify safe dosing ranges and how the body absorbs and clears these drugs, supporting future BPH treatment development.
How similar studies have performed: Phase 1 safety and pharmacokinetic trials are a standard and successful step in drug development, but these specific compounds are novel and their effects in humans are not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body weight equal to or greater than 50kg 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 adult male 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
- H PLUS YANGJI HOSPITAL, Seoul — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: JaeHun Jung
- Email: jhjung@addpharma.co.kr
- Phone: +82-31-891-5683
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.