Neuropathic Pain study: ASCT-83
Official title Safety, Tolerability, and Pharmacokinetics of ASCT-83 in Healthy Adults
ClinicalTrials.gov ID: NCT07363395
What this study is testing
What is ASCT-83?
ASCT-83 is an investigational medicine, given as a once-daily injectable medicine, being studied as a potential treatment for neuropathic pain.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if ASCT-83 is safe, what side effects it may cause, and how it is absorbed, distributed, and eliminated.
- Who it's for
- Healthy adult volunteers.
- What's involved
- Participants receive a single dose or a daily dose for 7 days of ASCT-83 or a placebo, stay in the clinic for 5‑day or 11‑day periods, and undergo health checkups and tests, with up to three additional outpatient visits.
- Time commitment
- Up to 11 days in the clinic plus up to three outpatient visits.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
You may be able to join if
- 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
- agree to follow the study contraceptive requirements from screening through 28 days after the final dose of study drug.
You likely can't join if
- 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...
- have evidence of liver disease or abnormal liver tests (ALT/AST, Alk Phos, GGT, or bilirubin \> ULN)
- 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...
- have a history of heart disease, including abnormal heart rhythm, heart attack, long QT syndrome, or abnormal heart rhythm findings on screening ECG...
- are currently receiving medications that affect or suppress the immune system, including steroids given by any route.
See the full eligibility criteria
- 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
- agree to follow the study contraceptive requirements from screening through 28 days after the final dose of study drug.
- agree to undergo pregnancy testing, including a negative pregnancy test at screening and at admission.
- agree not to donate ova (eggs) from screening through 28 days after the final dose of study drug.
- 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
- agree to be willing to abstain from sperm donation from screening through 90 days after final study drug administration
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Saint Paul, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Saint Paul, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.