MedTrace Logo

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

NCT07363395 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-01-23

No results posted yet for this study

Summary

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.

Conditions

  • Neuropathic Pain

Interventions

DRUG

ASCT-83

ASCT-83 is a 23-amino acid, macrocyclic peptide with a molecular weight of approximately 3 kilodaltons under development for the treatment of neuropathic pain (NeP). ASCT-83 25 mg/mL sterile solution for injection consists of 25 mg of ASCT-83 drug substance dissolved in 1 mL of histidine buffer. The product also contains mannitol to adjust the osmolarity of the final product. The product is stored at -20°C prior to dilution to achieve the target dose.

DRUG

Placebo

Placebo solution contaninig the same histidine buffer and mannitol concentrations as ASCT-83, with polyoxyl 35 castor oil (0.1% w/v) added to match the appearance of the active solution.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Alcamena Stem Cell Therapeutics

    lead INDUSTRY

Principal Investigators

  • Edmund Nesti, PhD · Alcamena Stem Cell Therapeutics

  • Trisha Shamp, PhD, PA-C, ECG-BA, CVPA-BC · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Drug
Yes

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363395 on ClinicalTrials.gov