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

NCT07363395 · tracked via the Priya Life Science USA tracker

Sponsor

Alcamena Stem Cell Therapeutics

Phase

Phase 1

Started

2026-01-06

Last updated

2026-06-16

Condition(s) studied

Neuropathic Pain

Investigational drug(s) / intervention(s)

ASCT-83Placebo

ASCT-83: 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: 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 summary

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

Sex

ALL

Min age

18 Years

Max age

64 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

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 suicidality — 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.
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.

Trial sites (1)

Facility	City	Region	Status
Nucleus Network Minneapolis Clinic	Saint Paul	Minnesota	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07363395 on ClinicalTrials.gov ↗ ← All trials in the USA