ASCT-83 Safety Study
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Edmund Nesti, PhD
Principal Investigator
Alcamena Stem Cell Therapeutics
Trisha Shamp, PhD, PA-C, ECG-BA, CVPA-BC
Principal Investigator
Nucleus Network
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
11
Treatment groups
Experimental Treatment
Placebo Group
Total dose: 4 mg ASCT-83. Administration: two 1.5 mL subcutaneous injections of 1.33 mg/mL (second injection within 10 minutes of the first)
Total dose: 2 mg ASCT-83. Administration: two 1.5 mL subcutaneous injections of 0.67 mg/mL (second injection within 10 minutes of the first)
Total dose: 10 mg ASCT-83. Administration: two 1.5 mL subcutaneous injections of 3.33 mg/mL (second injection within 10 minutes of the first)
Total dose: 7.5 mg ASCT-83. Administration: two 1.5 mL subcutaneous injections of 2.5 mg/mL (second injection within 10 minutes of the first)
Total dose: 1 mg ASCT-83. Administration: two 1.5 mL subcutaneous injections of 0.33 mg/mL (second injection within 10 minutes of the first)
Total dose: 0.5 mg ASCT-83. Administration: two 1.5 mL subcutaneous injections of 0.17 mg/mL (second injection within 10 minutes of the first)
Two daily subcutaneous injections of 1.5 ml of ASCT-83 for 7 days, with the two daily injections given max 10 minutes apart. Dose to be determined.
Two daily subcutaneous injections of 1.5 ml of ASCT-83 for 7 days, with the two daily injections given max 10 minutes apart. Dose to be determined.
Two daily subcutaneous injections of 1.5 ml of ASCT-83 for 7 days, with the two daily injections given max 10 minutes apart. Dose to be determined.
One dose of placebo solution administered as two subcutaneous injections of 1.5 ml (second injection within 10 minutes of the first)
Two daily subcutaneous injections of 1.5 ml placebo for 7 days, with the two daily injections given max 10 minutes apart.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alcamena Stem Cell Therapeutics
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
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