NCT07103278

Brief Summary

The study compare and evaluate the safety and pharmacokinetic characteristics between the administration of AD-116 and the administration of AD-1161 in healthy adult male volunteers

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2025

Shorter than P25 for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

July 29, 2025

Last Update Submit

September 30, 2025

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

  • Area under the plasma concentration-time curve during dosing interval (AUCt)

    AUCt of AD-116

    pre-dose (0hour) to 72hours

  • Maximum concentration of drug in plasma (Cmax)

    Cmax of AD-116

    pre-dose (0hour) to 72hours

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1 : Reference Drug(AD-1161), Period 2 : Test Drug(AD-116)

Drug: AD-116Drug: AD-1161

Sequence B

EXPERIMENTAL

Period 1 : Test Drug(AD-116), Period 2 : Reference Drug(AD-1161)

Drug: AD-116Drug: AD-1161

Interventions

AD-116DRUG

AD-116 Oral Tablet

Sequence ASequence B
AD-1161DRUG

AD-1161 Oral Capsule

Sequence ASequence B

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

December 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share