RecruitingPhase 1NCT07444385

A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects

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


Sponsor

Addpharma Inc.

Enrollment

44 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects


Eligibility

Sex: MALEMin Age: 19 Years

Inclusion Criteria2

  • 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 Criteria2

  • Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration
  • Other exclusions applied

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Interventions

DRUGAD-116, AD-1161

Single-dose oral administration of AD-116 or AD-1161, according to randomized sequence.


Locations(1)

H PLUS YANGJI HOSPITAL, Seoul

Seoul, South Korea

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NCT07444385


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