Safety and how the body handles AD-116 and AD-1161 in healthy adult men

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.