NCT07444385 A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects
| NCT ID | NCT07444385 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Addpharma Inc. |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-02-26 |
| Primary Completion | 2026-04-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 44 participants in total. It began in 2026-02-26 with a primary completion date of 2026-04-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 Under Fed Conditions in Healthy Adult Male Subjects
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07444385 clinical trial?
This trial is open to male participants only, aged 19 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07444385 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07444385 currently recruiting?
Yes, NCT07444385 is actively recruiting participants. Contact the research team at jhjung@addpharma.co.kr for enrollment information.
Where is the NCT07444385 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07444385 clinical trial?
NCT07444385 is sponsored by Addpharma Inc.. The trial plans to enroll 44 participants.