Neuropathic PainPhase 1NCT07586514
A Study to Assess Safety, Tolerability and Exposure of 4ET1103 in Healthy Human Volunteers
A Phase 1 study testing LY4286533 in people with Neuropathic Pain, run by 4E Therapeutics at 1 site in United States.
Trial summary
This study will dose healthy human volunteers with either active drug (4ET1103) or placebo. Each study subject will receive a single dose of either active drug or placebo, and will then be monitored for safety, tolerability and exposure of active drug. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- LY4286533
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2025to 18 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females (sex at birth) between 18 and 65 years of age; inclusive based on the date of Screening.
- Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weigh at least 50 kg at Screening and Day -1.
- Provision of signed and dated, written informed consent prior to any study-specific procedures
- Female subjects have a negative serum pregnancy test result at Screening and negative urine pregnancy test result at Day -1.
- Female subjects with male partners must meet one of the following criteria:
- Using a medically acceptable form of birth control for at least 30 days prior to Screening (60 days on oral contraceptives) until 3 months following the last dose of study drug [e.g., hormonal contraceptives (oral, patch, injectable or vaginal ring), implantable device (implantable rod or intrauterine device), bilateral tubal ligation/tubal occlusion or a double barrier (e.g., diaphragm, cervical cap, condom in conjunction with spermicide or sponge)]. For female subjects using hormonal contraceptives, it is also required to use at least one additional form of contraception, i.e., implantable device (implantable rod or intrauterine device), or a double barrier method (e.g., diaphragm, cervical cap, or condom in conjunction with spermicide or sponge).
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- Surgically sterile for at least 3 months prior to Screening by one of the following means:
- Bilateral salpingectomy (with or without oophorectomy)
- Surgical hysterectomy
- Bilateral oophorectomy (with or without hysterectomy)
- Postmenopausal, defined as the following:
- Female subjects with 12 months consecutive amenorrhea and follicle-stimulating hormone (FSH) levels greater than 40 international units per liter (IU/L) at Screening.
- Female subjects of reproductive potential who are abstinent of heterosexual activity (when in line with the preferred and usual lifestyle of the subject), are acceptable provided they agree to a double barrier method for at least 3 months after their last dose of the study drug should they become sexually active with a male partner.
- Females must agree to avoid egg donation throughout the study and for at least 3 months after last dose of study drug.
- Male subjects with female partners have history of vasectomy or must agree to utilize a highly effective method of contraception (condom with spermicide) during heterosexual intercourse from clinic admission until at least 3 months following the last dose of the study drug and must refrain from donating sperm for this same period.
- Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs at Screening and Day -1.
- Willing and able to adhere to study restrictions and to be confined at the clinical research center
- Subjects willing to defer receiving any vaccines (e.g. influenza or coronavirus or pneumococcal vaccines) within 30 days prior to the first dose of study drug (Day 1) and throughout the study.
- Nicotine-free (cigarettes, pipe, cigar, chewing tobacco, nicotine patches, vapes, etc.) for at least 3 months before Screening and a negative urine cotinine test at Screening and Day -1.
Who cannot join
- History or presence of any illness, condition, or finding that in the opinion of the Principal Investigator (PI) or designee would put the subject or study conduct at risk, or have the potential to confound the results of the study, if the subject were to participate in the study.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, bleeding disorder or psychiatric disease or drug hypersensitivity as determined by the Investigator
- Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the drug. Cholecystectomies will be exclusionary and uncomplicated appendectomies will not be exclusionary
- In opinion of the Investigator, the subject has history of any true drug allergy; excluding histories limited to mild to moderate gastrointestinal distress (nausea, anorexia, diarrhea, infrequent vomiting).
- History of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 360 mL of beer, or 37 mL of spirits, or 120 mL of wine) within 3 months prior to Screening, or positive urine alcohol test at Screening or Day -1. Subjects must agree to abstain from alcohol intake from 72 hours before study drug administration through discharge from the CRU.
- History of prescription drug abuse, or marijuana or cannabis product use or illicit drug use within 6 months prior to Screening, or positive findings on the urine drug screen at Screening or Day -1.
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- History of organ transplant, including history of bone marrow transplant.
- Use of any prescription (excluding contraceptives) medication, over the counter (OTC) medication or herbal supplements within 7 days or 5 half-lives, whichever is longer prior to Day 1.
- Evidence of severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) infection or oral temperature >38°C at Day -1. During the study, if subjects have infections, the subjects may continue the study at the discretion of the Investigator. In the case of COVID-19 infection, subject will be withdrawn.
- Subjects who have received any vaccines within 30 days prior to Day 1
- Donated or lost blood >500 ml within 60 days prior to Screening
- Acute illness within 14 days of study Day 1; acute illness occurring before this must show complete recovery at least 14 days prior to Day 1.
- Regular consumption of > 3caffeine - or xanthine-containing products in 2 weeks before Screening and unwilling to consume <3 caffeine - or xanthine-containing products while confined at the CRU.
- Positive serologic findings for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (Ab), and/or Human immunodeficiency virus (HIV) Ab at Screening.
- Positive Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
- Surgery within the past 90 days prior to Day 1 as determined by the Investigator to be clinically relevant.
- Seated systolic blood pressure (SBP) not within the range of 90 mmHg to 140 mmHg and diastolic blood pressure (DBP) not within the range of 50 mmHg to 90 mmHg at Screening or Day 1.
- Note: If a subject fails to meet SBP and/or DBP criteria, optional repeat visits/measurements can, at the discretion of the Investigator, to be completed. For those subjects who have a repeat blood pressure measurement, the repeat value will be used to determine eligibility.
- Heart rate <40 bpm or >99 bpm at Screening or Day -1. Note: If a subject fails to meet heart rate criteria, optional repeat visits/measurements can, at the discretion of the Investigator, to be completed. For those subjects who have a repeat blood pressure measurement, the repeat value will be used to determine eligibility.
- Any clinically significant ECG abnormality at Screening (as deemed by the Investigator).
- NOTE: The following (a-d) are considered not clinically significant without consulting Sponsor's Medical Monitor:
- Mild first-degree A-V block (P-R interval <0.23 sec)
- Right or left axis deviation
- Incomplete right bundle branch block
- Isolated left anterior fascicular block (left anterior hemiblock)
- QTcF interval >450 msec for male and >470 msec for female (the average value for the triplicate ECG at Screening and Day -1), or history of prolonged QT syndrome.
- Subject with abnormal liver function test (LFT) at Screening or Day -1.
- Subjects with estimated glomerular filtration rate (eGFR) < or = 75 mL/min/1.73m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 2021 at Screening or Day -1.
- Receipt of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing on Day 1.
- Subjects who have taken a special diet (including dragon fruit, mango, grapefruit or grapefruit juice and other known inhibitors of CYP) or strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 5 days before Day 1.
- Subjects with hypersensitivity to any excipients present in study drug (excipients listed in Investigator's Brochure).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First in Human Randomized, Double-Blind, Placebo Controlled Single Ascending Dose (SAD) Phase 1 Study to Determine Safety, Tolerability, and Pharmacokinetics of 4ET1103 in Healthy Volunteers
This study will dose healthy human volunteers with either active drug (4ET1103) or placebo. Each study subject will receive a single dose of either active drug or placebo, and will then be monitored for safety, tolerability and exposure of active drug.
Read the detailed description
This is a randomized, double-blind, placebo-controlled SAD study conducted in approximately 40 healthy male and female volunteers. The study drug (4ET1103 or placebo) will be administered orally under fasting condition. 40 subjects (8 subjects/cohort) will participate across 5 dose cohorts (45, 135, 270, 450 and 720 mg) of 4ET1103.
- Conditions
- Neuropathic Pain
- Being tested
- LY4286533, placebo
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4286533Drug
Also called 4ET1103
MNK inhibitor for treatment of neuropathic pain
placeboDrug
Placebo for MNK inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 active | Experimental | 45 mg active Receives: Drug: LY4286533 |
| Cohort 1 placebo | Placebo comparator | Placebo for 45 mg Receives: Drug: placebo |
| Cohort 2 active | Experimental | 135 mg active Receives: Drug: LY4286533 |
| Cohort 2 placebo | Placebo comparator | placebo for 135 mg Receives: Drug: placebo |
| Cohort 3 active | Experimental | 270 mg active Receives: Drug: LY4286533 |
| Cohort 3 placebo | Placebo comparator | placebo for 270 mg Receives: Drug: placebo |
| Cohort 4 active | Experimental | 450 mg active Receives: Drug: LY4286533 |
| Cohort 4 placebo | Placebo comparator | placebo for 450 mg Receives: Drug: placebo |
| Cohort 5 active | Experimental | 720 mg active Receives: Drug: LY4286533 |
| cohort 5 placebo | Placebo comparator | placebo for 720 mg Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hematology parameters
Hematology laboratory parameters (for example, complete blood count including erythrocytes, leukocytes with differential, hemoglobin, hematocrit, and platelets) will be summarized as observed values and changes from baseline at each postdose time point, and the number of subjects with clinically significant abnormalities will be reported.
Measured: 14 days
Change from baseline in serum chemistry parameters
Serum chemistry laboratory parameters (for example, electrolytes, liver function tests, renal function tests, and lipids) will be summarized as observed values and changes from baseline at each post dose time point, and the number of subjects with clinically significant abnormalities will be reported.
Measured: 14 days
Change from baseline in urinalysis parameters.
Urinalysis parameters (for example, urine specific gravity, pH, protein, glucose, ketones, blood/occult blood, nitrite, leukocyte esterase, and bilirubin) will be summarized as observed values and changes from baseline at each post dose time point, and the number of subjects with clinically significant abnormalities will be reported
Measured: 14 days
Change from baseline in coagulation parameters
Coagulation parameters (for example, prothrombin time, international normalized ratio, and activated partial thromboplastin time) will be summarized as observed values and changes from baseline at each post dose time point, and the number of subjects with clinically significant abnormalities will be reported.
Measured: 14 days
Change from bassline in vital signs
Vital signs, including systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature, will be summarized as observed values and changes from baseline at each postdose time point, and the number of subjects with clinically significant abnormalities will be reported.
Measured: 14 days
Change from baseline in 12-lead ECG parameters
Twelve-lead ECG parameters (for example, heart rate, PR interval, QRS duration, QT interval, and QTc) will be summarized as observed values and changes from baseline at each post dose time point, and the number of subjects with clinically significant ECG abnormalities will be reported.
Measured: 14 days
Incidence of treatment-emergent adverse events (TEAEs)
The number of subjects with treatment-emergent adverse events (TEAEs), including serious and non-serious AEs, will be summarized by system organ class and preferred term, severity, and relationship to study drug from first dose through the end of safety follow-up
Measured: 72 hours
Secondary outcomes (9)
Drug excreted in urine (Ae) to be determined.
The amount of drug excreted in urine will be calculated in milligrams
Measured: 24 hours after single dose 4ET1103
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) will be measured and reported in ng/mL.
Measured: PK measurements will be followed for out to 7 days from single dose of 4ET1103
Renal clearance (CLR) will be measured.
Renal clearance (CLR) will be presented in liters/hour (L/h)
Measured: 24 hours following single dose of 4ET1103
Fraction of dose excreted renally (Fe)
The fraction of dose excreted renally will be measured following oral single ascending dose administration
Measured: 24 hours following single dose of 4ET1103
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC) will be measured and reported (h x ng/mL)
Measured: PK measurements out to 7 days following single dose of 4ET1103
Time to maximum concentration (Tmax)
Tmax will be determined and reported in hours (h)
Measured: Monitoring up to 7 days following single dose of 4ET1103
Half life (T1/2) will be determined
Half life (T1/2) will be determined and reported in hours (h)
Measured: Monitoring for up to 7 days following single dose of 4ET1103
Apparent total body clearance (CL/F)
Apparent total body clearance (CL/F) will be determined and reported as liters/hour (L/h)
Measured: Up to 7 days following single dose of 4ET1103
Apparent volume of distribution (Vz/F)
Vz/F will be determined and reported in liters (L)
Measured: Up to 7 days following single dose of 4ET1103
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start18 Apr 2025
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- 4E Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristie Miller, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586514
- Sponsor's protocol ID
- 4ET1103-001
- Other IDs
- U44NS115692
- Status last verified
- Sep 2026
- First submitted
- 22 Apr 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Data contain proprietary information about an investigational new drug and cannot be disclosed prior to regulatory approval. Patient confidentiality also prohibits sharing due to detailed clinical and pharmacokinetic data from a small cohort.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Randomized, Double-Blind, Placebo Controlled Single Ascending Dose (SAD) Phase 1 Study to Determine Safety, Tolerability, and Pharmacokinetics of 4ET1103 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07586514
- Acronym / sponsor ID
- 4ET1103-001
- Conditions
- Neuropathic Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- 4E TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 14 May 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.
This study will dose healthy human volunteers with either active drug (4ET1103) or placebo. Each study subject will receive a single dose of either active drug or placebo, and will then be monitored for safety, tolerability and exposure of active drug.
Detailed description
This is a randomized, double-blind, placebo-controlled SAD study conducted in approximately 40 healthy male and female volunteers. The study drug (4ET1103 or placebo) will be administered orally under fasting condition. 40 subjects (8 subjects/cohort) will participate across 5 dose cohorts (45, 135, 270, 450 and 720 mg) of 4ET1103.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 active | Experimental | Drug: LY428653345 mg active |
| Cohort 1 placebo | Placebo comparator | Drug: placeboPlacebo for 45 mg |
| Cohort 2 active | Experimental | Drug: LY4286533135 mg active |
| Cohort 2 placebo | Placebo comparator | Drug: placeboplacebo for 135 mg |
| Cohort 3 active | Experimental | Drug: LY4286533270 mg active |
| Cohort 3 placebo | Placebo comparator | Drug: placeboplacebo for 270 mg |
| Cohort 4 active | Experimental | Drug: LY4286533450 mg active |
| Cohort 4 placebo | Placebo comparator | Drug: placeboplacebo for 450 mg |
| Cohort 5 active | Experimental | Drug: LY4286533720 mg active |
| cohort 5 placebo | Placebo comparator | Drug: placeboplacebo for 720 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Healthy males and females (sex at birth) between 18 and 65 years of age; inclusive based on the date of Screening.
- Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weigh at least 50 kg at Screening and Day -1.
- Provision of signed and dated, written informed consent prior to any study-specific procedures
- Female subjects have a negative serum pregnancy test result at Screening and negative urine pregnancy test result at Day -1.
- Female subjects with male partners must meet one of the following criteria:
Key exclusion criteria (31 listed)
- History or presence of any illness, condition, or finding that in the opinion of the Principal Investigator (PI) or designee would put the subject or study conduct at risk, or have the potential to confound the results of the study, if the subject were to participate in the study.
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, bleeding disorder or psychiatric disease or drug hypersensitivity as determined by the Investigator
- Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the drug. Cholecystectomies will be exclusionary and uncomplicated appendectomies will not be exclusionary
- In opinion of the Investigator, the subject has history of any true drug allergy; excluding histories limited to mild to moderate gastrointestinal distress (nausea, anorexia, diarrhea, infrequent vomiting).
- History of alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 360 mL of beer, or 37 mL of spirits, or 120 mL of wine) within 3 months prior to Screening, or positive urine alcohol test at Screening or Day -1. Subjects must agree to abstain from alcohol intake from 72 hours before study drug administration through discharge from the CRU.
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 |
|---|---|---|
| LY4286533Also: 4ET1103MNK inhibitor for treatment of neuropathic pain | Drug | Cohort 1 active, Cohort 2 active, Cohort 3 active, Cohort 4 active, Cohort 5 active |
| placeboPlacebo for MNK inhibitor | Drug | Cohort 1 placebo, Cohort 2 placebo, Cohort 3 placebo, Cohort 4 placebo, cohort 5 placebo |
Primary outcome
Change from baseline in hematology parameters
Time frame: 14 days
Hematology laboratory parameters (for example, complete blood count including erythrocytes, leukocytes with differential, hemoglobin, hematocrit, and platelets) will be summarized as observed values and changes from baseline at each postdose time point, and the number of subjects with clinically significant abnormalities will be reported.
Change from baseline in serum chemistry parameters
Time frame: 14 days
Serum chemistry laboratory parameters (for example, electrolytes, liver function tests, renal function tests, and lipids) will be summarized as observed values and changes from baseline at each post dose time point, and the number of subjects with clinically significant abnormalities will be reported.
Change from baseline in urinalysis parameters.
Time frame: 14 days
Urinalysis parameters (for example, urine specific gravity, pH, protein, glucose, ketones, blood/occult blood, nitrite, leukocyte esterase, and bilirubin) will be summarized as observed values and changes from baseline at each post dose time point, and the number of subjects with clinically significant abnormalities will be reported
Change from baseline in coagulation parameters
Time frame: 14 days
Coagulation parameters (for example, prothrombin time, international normalized ratio, and activated partial thromboplastin time) will be summarized as observed values and changes from baseline at each post dose time point, and the number of subjects with clinically significant abnormalities will be reported.
Change from bassline in vital signs
Time frame: 14 days
Vital signs, including systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature, will be summarized as observed values and changes from baseline at each postdose time point, and the number of subjects with clinically significant abnormalities will be reported.
Change from baseline in 12-lead ECG parameters
Time frame: 14 days
Twelve-lead ECG parameters (for example, heart rate, PR interval, QRS duration, QT interval, and QTc) will be summarized as observed values and changes from baseline at each post dose time point, and the number of subjects with clinically significant ECG abnormalities will be reported.
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 72 hours
The number of subjects with treatment-emergent adverse events (TEAEs), including serious and non-serious AEs, will be summarized by system organ class and preferred term, severity, and relationship to study drug from first dose through the end of safety follow-up
9 secondary outcomes
Drug excreted in urine (Ae) to be determined.
Time frame: 24 hours after single dose 4ET1103
Peak Plasma Concentration (Cmax)
Time frame: PK measurements will be followed for out to 7 days from single dose of 4ET1103
Renal clearance (CLR) will be measured.
Time frame: 24 hours following single dose of 4ET1103
Fraction of dose excreted renally (Fe)
Time frame: 24 hours following single dose of 4ET1103
Area under the plasma concentration versus time curve (AUC)
Time frame: PK measurements out to 7 days following single dose of 4ET1103
Time to maximum concentration (Tmax)
Time frame: Monitoring up to 7 days following single dose of 4ET1103
Half life (T1/2) will be determined
Time frame: Monitoring for up to 7 days following single dose of 4ET1103
Apparent total body clearance (CL/F)
Time frame: Up to 7 days following single dose of 4ET1103
Apparent volume of distribution (Vz/F)
Time frame: Up to 7 days following single dose of 4ET1103
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Data contain proprietary information about an investigational new drug and cannot be disclosed prior to regulatory approval. Patient confidentiality also prohibits sharing due to detailed clinical and pharmacokinetic data from a small cohort.
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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. This study is not recruiting at the moment.
Kristie Miller, MD principal investigator
PPD Development, LP
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 LY4286533 in people with Neuropathic Pain, run by 4E 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 19 inclusion and 31 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: finished, as of the sponsor's last update on 8 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hematology parameters (time frame: 14 days). The study lists 7 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 8 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.