NCT07531316

Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to do follow-up safety testing and how well people are able tolerate an experimental (not FDA approved) medication . This study is seeking non-illicit drug using adults to test the medication. Results of this study will help us to develop future studies to test the medication with people who use substances.

Detailed description

Adults between 18 and 65 years old will be recruited for the study. People who qualify for the study will be randomly (like the flip of a coin) assigned to take the study medication or placebo twice daily for 14 days. The study will include complete physical exams, bloodwork, ECGs of the heart, vital signs, psychological surveys and interviews, computer tasks, urine drug screens, completed over multiple study visits.

Conditions

• Healthy Controls

Interventions

Type	Name	Description
DRUG	Placebo pills for 14-day intervention	Subjects who are randomized to placebo will receive identical capsules to the study drug. During the 14-day intervention phase, participants will be instructed to take one capsule twice daily.
DRUG	VVZ-2471 for 14-day intervention	100 mg/BID. Subjects who are randomized to VVZ-2471 will receive identical capsules to the placebo. During the 14-day intervention phase, participants will be instructed to take one capsule twice daily.

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-12-20
• Completion: 2031-12-30
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study