Safety, Tolerability, and Pharmacokinetics of ASCT-83 in Healthy Adults
ConditionNeuropathic Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorAlcamena Stem Cell Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
be medically healthy based on medical history, physical exam, labs, and ECG
be 18-64 years (inclusive)
at screening, have a body mass index (BMI) > 19 to < 35 kg/m²
be willing and able to understand and voluntarily sign an informed consent
Disqualifiers
are a study site staff, Alcamena employee or immediate family member, or have participated in another clinical trial within 30 days or 5 half-lives of a prior investigational product.
have evidence of liver disease or abnormal liver tests (ALT/AST, Alk Phos, GGT, or bilirubin > ULN); positive hepatitis B or C serology (people with Gilbert syndrome may be included).
have a history of kidney disease, protein in the urine or reduced kidney function based on screening blood tests.
have a history of cancer with active disease, suspected relapse, treatment within 6 months, or ongoing therapy affecting immune, liver, or kidney function.
Trial design
Treatments tested in this trial
- ASCT-83
- Placebo
Treatment groups
72 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Locations
1Nucleus Network Minneapolis Clinic55114-5000, Saint PaulMinnesota, United States
Sponsors and collaborators
Alcamena Stem Cell Therapeutics
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov