drugset / Trial / NCT06808932
VK4-116 Phase I Study With Food-Effect
Phase 1
Not yet recruiting
48 enrolled
National Institute on Drug Abuse (NIDA)
Altasciences Company Inc. · collab
RandomizedSequentialQuadruple-blindTreatment
Summary
This first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD), phase I study is designed to assess the safety, tolerability and pharmacokinetics of VK4-116 in healthy volunteers in fasted and fed state.
Timeline
- Start
- 2026-08-01
- Primary completion
- 2027-04-30
- Completion
- 2027-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VK4-116 | Unknown | 50 mg | Oral |
| Subject | VK4-116 | Unknown | 100 mg | Oral |
| Subject | VK4-116 | Unknown | 200 mg | Oral |
| Subject | VK4-116 | Unknown | 400 mg | Oral |
| Subject | VK4-116 | Unknown | 500 mg | Oral |