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

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
Alcamena Stem Cell Therapeutics
Study ID
NCT07363395
Phase
PHASE1
Status
Recruiting
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Conditions

  • Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • ASCT-83 — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 6, 2026
Status verified
Jun 2026
Primary completion
Oct 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: SAD-Placebo
    One dose of placebo solution administered as two subcutaneous injections of 1.5 ml (second injection within 10 minutes of the first)
  • Experimental: SAD, ASCT-83 dose 1
    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)
  • Experimental: SAD, ASCT-83 dose 2
    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)
  • Experimental: SAD-ASCT dose 3
    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)
  • Experimental: SAD-ASCT dose 4
    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)
  • Experimental: SAD, ASCT-83 dose 5
    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)
  • Experimental: SAD, ASCT-83 dose 6
    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)
  • Placebo Comparator: MAD-Placebo
    Two daily subcutaneous injections of 1.5 ml placebo for 7 days, with the two daily injections given max 10 minutes apart.
  • Experimental: MAD, ASCT-83 dose 1
    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.
  • Experimental: MAD, ASCT-83 dose 2
    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.
  • Experimental: MAD, ASCT-83 dose 3
    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.

Primary Outcome Measure

Incidence, severity and dose relationships of Treatment-Emergent Adverse Events (TEAEs) and non-TEAEs, Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), premature treatment and study discontinuation due to Adverse Events (AEs) [ Time Frame: Single dose part of the study: from enrollment to 30-32 days after the end of treatment. Multiple dose part of the study: from enrollment to 36-38 days after the end of treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nucleus Network Minneapolis ClinicSaint PaulMinnesota55114-5000
Alissa Anderson
[email protected]
651-583-8518
Trisha Shamp
651-641-2900
Trisha Shamp (PRINCIPAL_INVESTIGATOR)

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