Food Effect in Healthy VolunteersPhase 1NCT07903337
A Phase 1, Open-Label, Two-Stage, Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-1071 Under Fasted or Fed Conditions in Healthy Volunteers
A Phase 1 study testing EI-1071 in people with Food Effect in Healthy Volunteers, run by Elixiron Immunotherapeutics Inc. at 1 site in Taiwan.
Trial summary
This is a phase 1, open-label, two-stage, sequential food effect study to evaluate the safety, tolerability, and PK of EI-1071 under fasted or fed conditions in HVs. Approximately 25 evaluable participants will be enrolled in this study, including 11 participants in Stage 1 and 14 participants in Stage 2. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Effect in Healthy Volunteers
- What is being tested?
- EI-1071
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2026to Aug 2027
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-lactating and non-pregnant female, aged 18 to 55 years old at the Screening Visit.
- Body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 and body weight ≥ 50 kilograms at the Screening Visit.
- Note: Participants who will participate in four periods in stage 1 (Dose Levels 1 and 2) must weigh greater than 60 kg at screening.
- Able to speak, read, and understand the language of the ICF, the nature of the study, and any potential risk associated with the IP and willing to provide written informed consent, to communicate with the Investigator, and to comply with all study visits, procedures, requirements, and restrictions.
- Mentally and physically healthy according to medical history, physical examination, vital signs, laboratory tests, and 12-lead ECG as determined by the Investigator.
- Reproductive and Contraceptive Status Requirements
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- Female participants: Must not be pregnant, nor breastfeeding
- Female participants with childbearing potential must have a negative result of serum pregnancy test at the Screening Visit; and must not plan to become pregnant during the study until 5 half-lives of EI-1071+ 30 days after the last administration of EI-1071
- - A female is considered to be of childbearing potential unless she:
- has had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy documented in medical history
- has been amenorrhoeic for consecutive ≥ 12 months (including no irregular menses or spotting) in the absence of any medication which induces a menopausal state and has documented ovarian insufficiency by follicle stimulating hormone [FSH] levels within the institutional laboratory postmenopausal range).
- Female participants with childbearing potential and male participants with reproductive potential must agree to refrain from unprotected sex and use two methods of medically acceptable contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm plus spermicide], non-hormonal intrauterine device [IUD]) or abstain from sexual intercourse from the Screening Visit until 5 half-lives of EI-1071 + 30 days after the last dose of EI-1071 for female participants, and until 5 half-lives of EI-1071 + 90 days after the last dose of EI-1071 for male participants.
- Male participants must agree to refrain from sperm donation, and female participants must agree to refrain from ova donation from Study Day -1 until 5 half-lives of EI-1071 + 90 days after the last dose of the IP.
- Note: For participants who consent to CBSF sampling in Stage 2, the absence of tumor, hemorrhage (including asymptomatic), or any clinically significant findings have to be evaluated and confirmed by the Investigator based on the brain CT scan prior to CBSF sampling.
Who cannot join
- History of allergy or hypersensitivity or clinically significant idiosyncratic reaction to EI-1071 or any component of this formulation (e.g., hydroxypropyl methylcellulose acetate succinate).
- Current or historical evidence of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, immunodeficiency, pulmonary, or other disorder, disease, or condition, that in the opinion of the Investigator, may increase the risk of IP or affect drug absorption, distribution, metabolism, or excretion.
- History of neoplastic or malignant disease (except for localized skin cancer without metastases).
- Known history of gastrointestinal surgery unless determined as non-clinically significant by the Investigator. Participants with a history of appendectomy or hemorrhoidectomy may be included at the discretion of the Investigator.
- A clinically significant vital signs abnormality, as judged by the Investigator. This includes, but is not limited to, the following (values obtained in the supine position with rest for at least 5 minutes before blood pressure assessment): systolic blood pressure < 90 or > 150 mmHg, diastolic blood pressure < 50 or > 95 mmHg, or heart rate < 45 or > 100 beats per minute. One repeat measurement is allowed for eligibility purposes at the Screening Visit and on Day -1.
- Significantly abnormal 12-lead ECG or QT prolongation (e.g., QTcF > 450 ms) at the Screening Visit, deemed unsuitable for participation in the trial as judged by the Investigator.
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- Positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody as defined by serology tests at the Screening Visit.
- Positive for amphetamine (AMP), cocaine (COC), opiates (morphine), and cannabinoid (THC) as defined by urine tests at the Screening Visit or Check-in Visit.
- Positive serum alcohol test result, defined as a result above the laboratory-defined lower limit of quantification (or detection) at Screening Visit or Check-in Visit.
- Onset of influenza-like symptoms as defined by: fever (temperature ≥ 38℃), dry cough, headache, fatigue, respiratory sputum production, dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat within 1 week prior to the Screening Visit.
- Receipt of vaccination within 30 days prior to the first administration of the IPs or plan to receive vaccination during the study.
- Use of any prescription or over-the-counter (OTC) medication, including oral contraceptives, oral multivitamins, herbal and/or dietary supplements within 30 days prior to the first administration of the IP (except topical agents without systemic absorption, as determined by the Investigator).
- Administration of any investigational drug other than EI-1071 within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to the first administration of the IP; or planned administration of another investigational drug or procedure during the study.
- Consumption of products containing caffeine/methylxanthines, poppy seeds, and/or alcohol within 48 hours before the first administration of the IPs and products containing grapefruit and/or pomelo (shown to inhibit cytochrome P450 [CYP] 3A4 activity) or St John's wort (Hypericum perforatum; shown to induce CYP3A4 activity) within 14 days prior to the first administration of the IP.
- Receipt of any blood, plasma, or platelet transfusions within 3 months prior to the first administration of the IP.
- Blood donation or blood loss of more than 250 mL within 3 months prior to the first administration of the IP.
- Use of any tobacco- or nicotine-containing products within 3 months prior to the first administration of the IP or during the study.
- History of regular alcohol consumption within 3 months of Day 1, defined as an average intake of > 15 alcoholic drinks per week in males and > 8 alcoholic drinks per week in females. One drink (14 g alcohol) is equivalent to 150 mL of wine, 360 mL of beer, or 45 mL of 80 proof distilled spirits. Participants who have consumed any alcohol products within 48 hours prior to the first administration of the IP will not be enrolled in the study.
- History of addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years prior to the Screening Visit.
- Participant who is considered unfit to participate in the clinical study based on the judgment of the Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a phase 1, open-label, two-stage, sequential food effect study to evaluate the safety, tolerability, and PK of EI-1071 under fasted or fed conditions in HVs. Approximately 25 evaluable participants will be enrolled in this study, including 11 participants in Stage 1 and 14 participants in Stage 2. Stage 2 study may be conducted based on the results of Stage 1 study.
- Conditions
- Food Effect in Healthy Volunteers
- Being tested
- EI-1071
- Keywords
- EI-1071, Healthy volunteers, CSF1R inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EI-1071Drug
EI-1071 tablet, oral
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 Dose Level 1 | Experimental | Not described Receives: Drug: EI-1071 |
| Stage 1 Dose Level 2 | Experimental | Not described Receives: Drug: EI-1071 |
| Stage 2 | Experimental | Not described Receives: Drug: EI-1071 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1 Area under the curve [AUC] from time 0 to the last quantifiable time [AUC0-t]
Measured: Day 1 to Day 4 of each single dose period
Stage 1 AUC from time 0 to infinity [AUC0-∞], and maximum concentration [Cmax]
Measured: Day 1 to Day 4 of each single dose period
Stage 1 Time to Cmax (Tmax)
Measured: Day 1 to Day 4 of each single dose period
Stage 1 Half-life (t1/2)
Measured: Day 1 to Day 4 of each single dose period
Stage 1 Apparent clearance (CL/F)
Measured: Day 1 to Day 4 of each single dose period
Stage 1 Apparent volume of distribution (Vz/F)
Measured: Day 1 to Day 4 of each single dose period
Stage 2 Incidence and severity of TEAEs and TESAEs,
Measured: From Day 1 to Day 21 (EOS visit)
Stage 2 Physical examination
Measured: Screening, Day -1, Day 21
Stage 2 Vital signs
Measured: Screening, Day -1 to Day 21
Stage 2 Laboratory tests
Hematology, biochemistry, urinalysis, and coagulation
Measured: Screening, Day -1, Day 7, Day 14, Day 21
Stage 2 12-lead ECG
Measured: Screening, Day 1, Day 14, Day 21
Secondary outcomes (18)
Stage 1 Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Measured: From Day 1 to EOS visit
Stage 1 Physical examination
Measured: Screening, Day -1, Day 4, Day 7 of each single dose period
Stage 1 Vital signs
Measured: Screening, Day -1, Day 1, Day 2, Day 3, Day 4, Day 7 of each single dose period
Stage 1 Laboratory tests
Hematology, biochemistry, urinalysis, and coagulation
Measured: Screening, Day -1, Day 4, Day 7 of each single dose period
Stage 1 12-lead electrocardiogram (ECG)
Measured: Screening, Day 1, Day 4, Day 7 of each single dose period
Stage 2 AUC during a dosing interval (AUCτ)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 AUC from 0 to 24 hours (AUC0-24)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Cmax
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Tmax
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 AUC during a dosing interval at steady state (AUCτ,ss)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 AUC0-24 at steady state (AUC0-24,ss)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Maximum concentration at steady state (Cmax,ss)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Concentration at the end of dosing interval at steady state (Ctrough,ss)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Time to Cmax at steady state (Tmax,ss)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Accumulation ratio (Rac)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Half-life (t1/2)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Apparent clearance (CL/F)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Apparent volume of distribution (Vz/F)
Measured: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Effect in Healthy VolunteersStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elixiron Immunotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903337
- Sponsor's protocol ID
- EI-1071-102
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Two-Stage, Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-1071 Under Fasted or Fed Conditions in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07903337
- Acronym / sponsor ID
- EI-1071-102
- Conditions
- Food Effect in Healthy Volunteers
- Keywords
- EI-1071, Healthy volunteers, CSF1R inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Elixiron Immunotherapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University Hospital
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 29 Oct 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 is a phase 1, open-label, two-stage, sequential food effect study to evaluate the safety, tolerability, and PK of EI-1071 under fasted or fed conditions in HVs. Approximately 25 evaluable participants will be enrolled in this study, including 11 participants in Stage 1 and 14 participants in Stage 2. Stage 2 study may be conducted based on the results of Stage 1 study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage 1 Dose Level 1 | Experimental | Drug: EI-1071 |
| Stage 1 Dose Level 2 | Experimental | Drug: EI-1071 |
| Stage 2 | Experimental | Drug: EI-1071 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or non-lactating and non-pregnant female, aged 18 to 55 years old at the Screening Visit.
- Body mass index (BMI) ranging from 18.0 to 30.0 kg/m2 and body weight ≥ 50 kilograms at the Screening Visit.
- Note: Participants who will participate in four periods in stage 1 (Dose Levels 1 and 2) must weigh greater than 60 kg at screening.
- Able to speak, read, and understand the language of the ICF, the nature of the study, and any potential risk associated with the IP and willing to provide written informed consent, to communicate with the Investigator, and to comply with all study visits, procedures, requirements, and restrictions.
- Mentally and physically healthy according to medical history, physical examination, vital signs, laboratory tests, and 12-lead ECG as determined by the Investigator.
Key exclusion criteria (20 listed)
- History of allergy or hypersensitivity or clinically significant idiosyncratic reaction to EI-1071 or any component of this formulation (e.g., hydroxypropyl methylcellulose acetate succinate).
- Current or historical evidence of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, immunodeficiency, pulmonary, or other disorder, disease, or condition, that in the opinion of the Investigator, may increase the risk of IP or affect drug absorption, distribution, metabolism, or excretion.
- History of neoplastic or malignant disease (except for localized skin cancer without metastases).
- Known history of gastrointestinal surgery unless determined as non-clinically significant by the Investigator. Participants with a history of appendectomy or hemorrhoidectomy may be included at the discretion of the Investigator.
- A clinically significant vital signs abnormality, as judged by the Investigator. This includes, but is not limited to, the following (values obtained in the supine position with rest for at least 5 minutes before blood pressure assessment): systolic blood pressure < 90 or > 150 mmHg, diastolic blood pressure < 50 or > 95 mmHg, or heart rate < 45 or > 100 beats per minute. One repeat measurement is allowed for eligibility purposes at the Screening Visit and on Day -1.
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 |
|---|---|---|
| EI-1071EI-1071 tablet, oral | Drug | Stage 1 Dose Level 1, Stage 1 Dose Level 2, Stage 2 |
Primary outcome
Stage 1 Area under the curve [AUC] from time 0 to the last quantifiable time [AUC0-t]
Time frame: Day 1 to Day 4 of each single dose period
Stage 1 AUC from time 0 to infinity [AUC0-∞], and maximum concentration [Cmax]
Time frame: Day 1 to Day 4 of each single dose period
Stage 1 Time to Cmax (Tmax)
Time frame: Day 1 to Day 4 of each single dose period
Stage 1 Half-life (t1/2)
Time frame: Day 1 to Day 4 of each single dose period
Stage 1 Apparent clearance (CL/F)
Time frame: Day 1 to Day 4 of each single dose period
Stage 1 Apparent volume of distribution (Vz/F)
Time frame: Day 1 to Day 4 of each single dose period
Stage 2 Incidence and severity of TEAEs and TESAEs,
Time frame: From Day 1 to Day 21 (EOS visit)
Stage 2 Physical examination
Time frame: Screening, Day -1, Day 21
Stage 2 Vital signs
Time frame: Screening, Day -1 to Day 21
Stage 2 Laboratory tests
Time frame: Screening, Day -1, Day 7, Day 14, Day 21
Hematology, biochemistry, urinalysis, and coagulation
Stage 2 12-lead ECG
Time frame: Screening, Day 1, Day 14, Day 21
18 secondary outcomes
Stage 1 Incidence and severity of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Time frame: From Day 1 to EOS visit
Stage 1 Physical examination
Time frame: Screening, Day -1, Day 4, Day 7 of each single dose period
Stage 1 Vital signs
Time frame: Screening, Day -1, Day 1, Day 2, Day 3, Day 4, Day 7 of each single dose period
Stage 1 Laboratory tests
Time frame: Screening, Day -1, Day 4, Day 7 of each single dose period
Stage 1 12-lead electrocardiogram (ECG)
Time frame: Screening, Day 1, Day 4, Day 7 of each single dose period
Stage 2 AUC during a dosing interval (AUCτ)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 AUC from 0 to 24 hours (AUC0-24)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Cmax
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Tmax
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 AUC during a dosing interval at steady state (AUCτ,ss)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 AUC0-24 at steady state (AUC0-24,ss)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Maximum concentration at steady state (Cmax,ss)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Concentration at the end of dosing interval at steady state (Ctrough,ss)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Time to Cmax at steady state (Tmax,ss)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Accumulation ratio (Rac)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Half-life (t1/2)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Apparent clearance (CL/F)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
Stage 2 Apparent volume of distribution (Vz/F)
Time frame: From pre-dose on Day 1 to 12 hours after the morning administration on Day 14
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 29 Oct 2026.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
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 EI-1071 in people with Food Effect in Healthy Volunteers, run by Elixiron Immunotherapeutics Inc. at 1 site in Taiwan.
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 14 inclusion and 20 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: opening soon, as of the sponsor's last update on 29 Oct 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 Taiwan. 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. 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 Project Manager (+886-27827700, yachien@elixiron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1 Area under the curve [AUC] from time 0 to the last quantifiable time [AUC0-t] (time frame: Day 1 to Day 4 of each single dose period). The study lists 11 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 29 Oct 2026.