Safety and how ASCT-83 behaves in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study tests ASCT-83, a CTDSP1 inhibitor, for safety, tolerability, and pharmacokinetics in healthy adults with neuropathic pain planning ongoing assessment. The trial has two parts: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase, each comparing ASCT-83 to placebo. Participants receive subcutaneous injections in a controlled clinic setting, with sentinel dosing and close monitoring before cohort dosing proceeds. Dosing will be escalated in steps based on safety data and may expand to additional cohorts as data emerge.

Why it matters

Who can join: the full rules

Inclusion Criteria:

To participate in the study, you must:

* 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
* Female participants of childbearing potential (women who can become pregnant) must:

  1. agree to follow the study contraceptive requirements from screening through 28 days after the final dose of study drug.
  2. agree to undergo pregnancy testing, including a negative pregnancy test at screening and at admission.
  3. agree not to donate ova (eggs) from screening through 28 days after the final dose of study drug.
* Male participants must:

  1. have a vasectomy greater than 6 months prior to screening or be willing to follow the contraceptive requirements from screening through 90 days after final study drug administration
  2. agree to be willing to abstain from sperm donation from screening through 90 days after final study drug administration

Exclusion Criteria:

You cannot participate in the study if you:

* 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.
* have a history of heart disease, including abnormal heart rhythm, heart attack, long QT syndrome, or abnormal heart rhythm findings on screening ECG, or a family history of sudden unexplained death.
* are currently receiving medications that affect or suppress the immune system, including steroids given by any route.
* have a known autoimmune condition (such as lupus, rheumatoid arthritis, sarcoidosis, or vitiligo), even if it is not being treated.
* have a positive HIV test at screening or a history of immune deficiency.
* have abnormal blood tests suggesting ongoing inflammation
* have an active infection or is currently being treated for an infection.
* have a skin condition that could interfere with study skin assessments (such as psoriasis).
* are allergic or sensitive to the study drug or its ingredients.
* have a history of alcohol or drug abuse or addiction within the past five years, have a positive drug or alcohol test at screening, or have smoked within one month before screening.
* have a serious mental health condition, such as major depression, schizophrenia, severe anxiety, eating disorders, severe attention deficit disorder, personality disorders, or suicidal thoughts or behavior within the past five years that could affect safety or study participation.
* have low blood pressure upon standing, defined as a significant drop in blood pressure when moving from lying down to standing during screening or baseline testing.
* have abnormally low white blood cell counts or neutrophil counts, unless this finding is due to a known benign condition such as benign ethnic neutropenia.

Where it's running

• Nucleus Network Minneapolis Clinic
  Saint Paul, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Trisha Shamp, PhD, PA-C, ECG-BA, CVPA-BC — Nucleus Network
• Study coordinator: Alissa Anderson
• Email: a.anderson@nucleusnetwork.com
• Phone: 651-583-8518

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.