Safety, Tolerability, and Pharmacokinetics of ASCT-83 in Healthy Adults

The goal of this clinical trial is to learn if ASCT-83 is safe and well-tolerated and measure how ASCT-83 is absorbed, distributed, and eliminated from the body over time. The study will be conducted in healthy adults. The main questions this study will answer are: * Is ASCT-83 safe at clinical doses? * Does ASCT-83 have side effects at clinical doses? * How is ASCT-83 absorbed, distributed, and eliminated from the body? Researchers will compare ASCT-83 to a placebo (a look-alike substance that contains no drug). The study has two parts: participants in Part 1 will receive only one dose of ASCT-83 or placebo participants in Part 2 will receive one dose of ASCT-83 or placebo a day for 7 days. Participants will visit the clinic to take ASCT-83 or placebo, to receive health checkups and undergo health tests. Participants in Part 1 will spend 5 days/4 nights in the clinic, participants in Part 2 will spend 11 days/10 nights in the clinic. In addition, there will be up to 3 outpatient visits. The results of this study will help determine safe dose levels and support the design of future clinical trials.

NCT Number	NCT07363395
Lead Sponsor	Alcamena Stem Cell Therapeutics Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Congressionally Directed Medical Research Programs
Conditions	Neuropathic Pain
Enrollment	72 participants
Start Date	2026-01-06
Primary Completion	2026-10-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-16