Neuropathic PainPhase 1NCT07363395
Safety, Tolerability, and Pharmacokinetics of ASCT-83 in Healthy Adults
A Phase 1 study testing ASCT-83 in people with Neuropathic Pain, run by Alcamena Stem Cell Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- ASCT-83
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 1 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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.
- Male participants must:
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nucleus Network Minneapolis Clinic
Saint Paul, Minnesota, 55114-5000
Alissa Anderson, 651-583-8518, a.anderson@nucleusnetwork.com
Trisha Shamp, 651-641-2900
About this study
Official title: A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASCT-83 Subcutaneous Injection in Healthy Adults
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:
Read more
- 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.
Read the detailed description
Seventy-two healthy participants will be randomized to the following groups:
- Part 1, Single Ascending Dose (SAD): Healthy adult participants (age 18-64, inclusive) will be enrolled in 6 dose cohorts: 0.5 mg, 1 mg, 2 mg, 4 mg, 7.5 mg, or 10 mg. Each cohort consists of 8 participants (6 ASCT-83, 2 placebo), totaling 48 participants.
- Part 2, Multiple Ascending Dose (MAD): 3 dose cohorts of 8 participants each (6 ASCT-83, 2 placebo), totaling 24 participants. Dosing and regimens for Part 2 will be determined following review of SAD data by the Data Safety Monitoring Committee (DSMC).
All doses (ASCT-83 or placebo) will be administered as two subcutaneous (SC) injections (arm or thigh), with the second injection occurring within 10 minutes of the first.
The first two participants in every cohort - one administered ASCT-83 and one administered placebo - will be the sentinel participants. In every cohort, the two sentinel participants must be observed for 72 hours before the rest of the cohort is dosed.
The maximum dose escalation increment between any two cohorts will be two-fold. The maximum daily dose will not exceed the maximum tolerated dose established in the SAD study.
Additional cohorts may be recruited based on the emerging safety, tolerability, and PK data.
- Conditions
- Neuropathic Pain
- Being tested
- ASCT-83, Placebo
- Keywords
- Neuropathic Pain, Nerve Regeneration, Analgesic, CTDSP1 Inhibitor, REST (RE1-silencing transcription factor), Macrocyclic Peptide, Target Engagement, First-in-Human (FIH), SAD/MAD, Healthy Volunteers, Pharmacokinetics (PK), Diabetic Peripheral Neuropathy (DPN), Peripheral Nerve Injury (PNI)
- Medical subject headings
- Neuralgia, Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASCT-83Drug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| SAD-Placebo | Placebo comparator | One dose of placebo solution administered as two subcutaneous injections of 1.5 ml (second injection within 10 minutes of the first) Receives: Drug: Placebo |
| SAD, ASCT-83 dose 1 | Experimental | 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) Receives: Drug: ASCT-83 |
| SAD, ASCT-83 dose 2 | Experimental | 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) Receives: Drug: ASCT-83 |
| SAD-ASCT dose 3 | Experimental | 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) Receives: Drug: ASCT-83 |
| SAD-ASCT dose 4 | Experimental | 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) Receives: Drug: ASCT-83 |
| SAD, ASCT-83 dose 5 | Experimental | 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) Receives: Drug: ASCT-83 |
| SAD, ASCT-83 dose 6 | Experimental | 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) Receives: Drug: ASCT-83 |
| MAD-Placebo | Placebo comparator | Two daily subcutaneous injections of 1.5 ml placebo for 7 days, with the two daily injections given max 10 minutes apart. Receives: Drug: Placebo |
| MAD, ASCT-83 dose 1 | Experimental | 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. Receives: Drug: ASCT-83 |
| MAD, ASCT-83 dose 2 | Experimental | 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. Receives: Drug: ASCT-83 |
| MAD, ASCT-83 dose 3 | Experimental | 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. Receives: Drug: ASCT-83 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: 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 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).
Measured: 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
Suicide risk will be assessed through a questionnaire (Columbia-Suicide Severity Rating Scale (C-SSRS)). A score ≥4 is considered suicidal ideation.
Measured: 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 and type of abnormal skin assessments, including injection-site reactions.
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.
Measured: 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.
Secondary outcomes (11)
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of ASCT-83
Plasma concentration of ASCT-83 will be measured following a single dose of ASCT-83 (SAD part of the study) or multiple doses of ASCT-83 (MAD part of the study) to characterize the total exposure to ASCT-83.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Area under the concentration-time curve from time zero to 24 h (AUC0-24h) of ASCT-83
Plasma concentration of ASCT-83 will be measured following a single dose of ASCT-83 (SAD part of the study) or multiple doses of ASCT-83 (MAD part of the study) to characterize exposure to ASCT-83 over the last 24 h dosing interval.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Peak plasma concentration (Cmax) of ASCT-83
Plasma concentration of ASCT-83 will be measured to characterize the peak concentration of ASCT-83 in the blood following either a single dose (SAD part of the study) or multiple doses (MAD part of the study) of ASCT-83.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Time to reach maximum plasma concentration (Tmax) of ASCT-83
Plasma concentrations of ASCT-83 will be measured to determine the time at which the highest concentration of ASCT-83 is reached after either a single dose (SAD part of the study) or multiple doses of ASCT-83 (MAD part of the study).
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Terminal elimination half-life (t½) of ASCT-83
Concentrations of ASCT-83 in plasma will be measured to determine the time required for the drug concentration to decrease to half of its initial amount. Plasma concentrations will be measured both in the single dose (SAD) and the multiple dose (MAD) part of the study.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Apparent clearance (CL/F) of ASCT-83
Plasma clearance of ASCT-83 will be measured after both a single dose (SAD part of the study) and multiple doses (MAD part of the study) of ASCT-83.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Apparent volume of distribution (Vz/F) of ASCT-83
The distribution of ASCT-83 in the body (whether it stays in the blood or it spreads to the rest of the body) will be measured after a single dose (SAD part of the study) or multiple doses (MAD part of the study) of ASCT-83.
Measured: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Amount of ASCT-83 excreted in urine
Amount of ASCT-83 excreted in urine will be measured after a single dose of ASCT-83 (SAD part of the study).
Measured: Pre-dose, then at 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-36 hours, 36-48 hours, 48-60 hours, 60-72 hours post-dose.
Fraction of ASCT-83 excreted in urine unchanged
The proportion of ASCT-83 that is eliminated in urine in its original, active form will be measured after a single dose of ASCT-83 (SAD part of the study).
Measured: Pre-dose, then at 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-36 hours, 36-48 hours, 48-60 hours, 60-72 hours post-dose.
Renal clearance (CLR) of ASCT-83
The amount of ASCT-83 excreted in the urine during an interval of time will be measured after a single dose of ASCT-83 (SAD part of the study).
Measured: Pre-dose, then at 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-36 hours, 36-48 hours, 48-60 hours, 60-72 hours post-dose.
Incidence of anti-drug antibodies (ADA) and titers (in ADA positive participants).
Measured: Prior to initiation of dosing on Day 1, and on Days 7, 14, 25, 37.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start6 Jan 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcamena Stem Cell Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Edmund Nesti, PhD, Study director, Alcamena Stem Cell TherapeuticsTrisha Shamp, PhD, PA-C, ECG-BA, CVPA-BC, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363395
- Sponsor's protocol ID
- ASCT-83-101
- Other IDs
- 1R44NS145934-01, CDMRP-HT94252510912
- Status last verified
- Jun 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data is restricted to the Sponsor and oversight bodies (FDA/DoD)
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASCT-83 Subcutaneous Injection in Healthy Adults
- ClinicalTrials.gov ID
- NCT07363395
- Acronym / sponsor ID
- ASCT-83-101
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic Pain, Nerve Regeneration, Analgesic, CTDSP1 Inhibitor, REST (RE1-silencing transcription factor), Macrocyclic Peptide, Target Engagement, First-in-Human (FIH)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Alcamena Stem Cell TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Congressionally Directed Medical Research Programs
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Seventy-two healthy participants will be randomized to the following groups:
- Part 1, Single Ascending Dose (SAD): Healthy adult participants (age 18-64, inclusive) will be enrolled in 6 dose cohorts: 0.5 mg, 1 mg, 2 mg, 4 mg, 7.5 mg, or 10 mg. Each cohort consists of 8 participants (6 ASCT-83, 2 placebo), totaling 48 participants.
- Part 2, Multiple Ascending Dose (MAD): 3 dose cohorts of 8 participants each (6 ASCT-83, 2 placebo), totaling 24 participants. Dosing and regimens for Part 2 will be determined following review of SAD data by the Data Safety Monitoring Committee (DSMC).
All doses (ASCT-83 or placebo) will be administered as two subcutaneous (SC) injections (arm or thigh), with the second injection occurring within 10 minutes of the first.
The first two participants in every cohort - one administered ASCT-83 and one administered placebo - will be the sentinel participants. In every cohort, the two sentinel participants must be observed for 72 hours before the rest of the cohort is dosed.
The maximum dose escalation increment between any two cohorts will be two-fold. The maximum daily dose will not exceed the maximum tolerated dose established in the SAD study.
Additional cohorts may be recruited based on the emerging safety, tolerability, and PK data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| SAD-Placebo | Placebo comparator | Drug: PlaceboOne dose of placebo solution administered as two subcutaneous injections of 1.5 ml (second injection within 10 minutes of the first) |
| SAD, ASCT-83 dose 1 | Experimental | Drug: ASCT-83Total 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) |
| SAD, ASCT-83 dose 2 | Experimental | Drug: ASCT-83Total 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) |
| SAD-ASCT dose 3 | Experimental | Drug: ASCT-83Total 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) |
| SAD-ASCT dose 4 | Experimental | Drug: ASCT-83Total 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) |
| SAD, ASCT-83 dose 5 | Experimental | Drug: ASCT-83Total 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) |
| SAD, ASCT-83 dose 6 | Experimental | Drug: ASCT-83Total 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) |
| MAD-Placebo | Placebo comparator | Drug: PlaceboTwo daily subcutaneous injections of 1.5 ml placebo for 7 days, with the two daily injections given max 10 minutes apart. |
| MAD, ASCT-83 dose 1 | Experimental | Drug: ASCT-83Two 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. |
| MAD, ASCT-83 dose 2 | Experimental | Drug: ASCT-83Two 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. |
| MAD, ASCT-83 dose 3 | Experimental | Drug: ASCT-83Two 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASCT-83ASCT-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. | Drug | MAD, ASCT-83 dose 1, MAD, ASCT-83 dose 2, MAD, ASCT-83 dose 3, SAD, ASCT-83 dose 1, SAD, ASCT-83 dose 2, SAD, ASCT-83 dose 5, SAD, ASCT-83 dose 6, SAD-ASCT dose 3, SAD-ASCT dose 4 |
| PlaceboPlacebo 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. | Drug | MAD-Placebo, SAD-Placebo |
Primary outcome
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.
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).
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.
Incidence of suicidality
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.
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.
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.
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.
11 secondary outcomes
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of ASCT-83
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Area under the concentration-time curve from time zero to 24 h (AUC0-24h) of ASCT-83
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Peak plasma concentration (Cmax) of ASCT-83
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Time to reach maximum plasma concentration (Tmax) of ASCT-83
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Terminal elimination half-life (t½) of ASCT-83
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Apparent clearance (CL/F) of ASCT-83
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Apparent volume of distribution (Vz/F) of ASCT-83
Time frame: SAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose. MAD: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post-dose on Day 1; pre-dose on Days 3 to 7; 24, 36, 48, and 72 hours after the final dose on Day 7
Amount of ASCT-83 excreted in urine
Time frame: Pre-dose, then at 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-36 hours, 36-48 hours, 48-60 hours, 60-72 hours post-dose.
Fraction of ASCT-83 excreted in urine unchanged
Time frame: Pre-dose, then at 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-36 hours, 36-48 hours, 48-60 hours, 60-72 hours post-dose.
Renal clearance (CLR) of ASCT-83
Time frame: Pre-dose, then at 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-36 hours, 36-48 hours, 48-60 hours, 60-72 hours post-dose.
Incidence of anti-drug antibodies (ADA) and titers (in ADA positive participants).
Time frame: Prior to initiation of dosing on Day 1, and on Days 7, 14, 25, 37.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No. Participant data is restricted to the Sponsor and oversight bodies (FDA/DoD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edmund Nesti, PhD study director
Alcamena Stem Cell Therapeutics
Trisha Shamp, PhD, PA-C, ECG-BA, CVPA-BC principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASCT-83 in people with Neuropathic Pain, run by Alcamena Stem Cell Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alissa Anderson (651-583-8518, a.anderson@nucleusnetwork.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.