drugset / Trial / NCT06847698
Single Ascending Dose and Multiple Ascending Dose Study of AVR-48
Phase 1
Not yet recruiting
48 enrolled
AyuVis Research, Inc.
National Institutes of Health (NIH) · collab
RandomizedSequentialDouble-blindBasic science
Summary
This is a Phase 1 (healthy adult volunteers), 2-part, double-blind, randomized, placebo controlled trial to evaluate the safety and pharmacokinetic (PK) profiles of escalating single doses of AVR-48 versus placebo (SAD) and escalating multiple doses of AVR-48 versus placebo (MAD). SAD will be initiated first and include a sentinel dosing design. MAD will not utilize a sentinel design unless the safety monitoring committee requests the addition of sentinels. The MAD will be initiated once the lowest doses from SAD are deemed safe.
Timeline
- Start
- 2025-06
- Primary completion
- 2025-10
- Completion
- 2025-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AVR-48 | Small molecule | — | Intravenous |
Indications
No indication recorded.