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ASCT-83 for Neuropathic Pain: Safety and Tolerability Study

This study is testing a new medication called ASCT-83, which is being developed to treat neuropathic pain. Researchers want to understand if ASCT-83 is safe and well-tolerated in healthy adults, and how the body processes it. You would receive either ASCT-83 or a placebo (an inactive substance that looks like the study drug). The main goals are to identify any side effects and see how ASCT-83 is absorbed, distributed, and removed from the body. To join, you must be a healthy adult between 18 and 64 years old. The study aims to enroll 72 participants.

Study design
This interventional study will enroll 72 healthy adults, randomized to receive either ASCT-83 or a placebo. Some participants will receive a single dose, while others will receive daily doses for 7 days.
What's involved
You would undergo medical history review, physical exams, lab tests, ECGs, and skin assessments. You would receive ASCT-83 or placebo as two injections, and be observed for safety for up to 38 days after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for 30-32 days after a single dose, or 36-38 days after the last multiple dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07363395

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

Recruiting
PHASE1Ages 18–64InterventionalTreatment
Alcamena Stem Cell Therapeutics
~72 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:ASCT-83Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over 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.
+3 more outcomes measured

Conditions

Neuropathic Pain

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Healthy Volunteers

NCT07363395

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Nucleus Network Minneapolis Clinic

    Saint Paul, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Edmund Nesti, PhD · STUDY_DIRECTOR · Alcamena Stem Cell Therapeutics
  • Trisha Shamp, PhD, PA-C, ECG-BA, CVPA-BC · PRINCIPAL_INVESTIGATOR · Nucleus Network

Who to contact

Alissa Anderson
[email protected]
651-583-8518
Email the study team

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Eligibility criteria

Inclusion

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:
Male participants must:

Exclusion

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.

What this trial measures

  • 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)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.

    The investigator will assess and record information pertaining to the AE, which includes but is not limited to the following: date of onset, event diagnosis (when known) and/or signs and symptoms, duration, severity, seriousness (i.e. serious adverse event or not serious), expected/unexpected, and relationship to the study therapy or procedure, action(s) taken, and outcome. Severity grading: 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental ADL. 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. 4 Life-threatening consequences; urgent intervention indicated. 5 Death related to AE.

  • Incidence and severity of changes in clinical safety parameters, including vital signs (including body weight), laboratory (including markers of inflammation), ECG results, and skin assessments (including injection site reactions).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.
  • Incidence of suicidalitySingle 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.

    Suicide risk will be assessed through a questionnaire (Columbia-Suicide Severity Rating Scale (C-SSRS)). A score ≥4 is considered suicidal ideation.

  • Incidence and type of abnormal skin assessments, including injection-site reactions.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.

    The FDA Toxicity Grading Scale (TGS) for injection/vaccine sites will be used: Mild/Grade 1, Moderate/Grade 2, Severe/Grade 3, Life-threatening/Grade 4.