A Clinical Trial to Evaluate the Safety and the Pharmacokinetics of AD-116 Compared to AD-1161 in Healthy Adult Male Volunteers

Launched by ADDPHARMA INC. · Jul 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different versions of a medication, called AD-116 and AD-1161, to see how safe they are and how the body processes them. The study is being done in healthy adult men to better understand how these drugs work before they are tested in people with an enlarged prostate, a common condition called benign prostatic hyperplasia.

Men who are 19 years or older, weigh at least 50 kilograms (about 110 pounds), and have a body mass index (BMI) between 18 and 30 may be eligible to participate. Participants should be healthy and not have taken any other experimental drugs in the past six months. If selected, volunteers will receive either AD-116 or AD-1161, and researchers will carefully monitor their safety and how their bodies handle the medication. This study is not yet recruiting, so if you think you might be interested, it’s good to keep an eye out for future updates.

Gender

MALE

Eligibility 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