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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 16, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Recruitment openedv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Oct 2026 to Oct 1, 2026
    • Study completion date: Dec 2026 to Dec 1, 2026
    • Start date changed from estimate of Jan 2026 to Jan 6, 2026
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07363395
Lead Sponsor Alcamena Stem Cell Therapeutics
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Congressionally Directed Medical Research Programs
Conditions
(from sponsor)		 Neuropathic Pain
Related terms Neuralgia, Peripheral Nerve Injuries
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov