Healthy VolunteersPhase 1NCT04238364
A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers
A Phase 1 study testing EI-1071 in people with Healthy Volunteers, run by Elixiron Immunotherapeutics Inc. at 1 site in United States.
Trial summary
This was a first-in-human study to determine the safety, tolerability, and pharmacokinetics of EI1071 after single and multiple doses in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- EI-1071
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2019to 10 Jan 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects were eligible for enrollment in the study only if they met all the following criteria:
- Healthy male and female subjects, 18 to 45 years of age, inclusive. (Taiwan only: To be at least 20 years of age.)
- The subject had a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and weighs at least 50kg.
- The subject was in good health and has no medical condition of clinical significance or that may impact the outcome of the study, as determined by the investigator (as determined by medical history, physical examination, 12-lead electrocardiogram [ECG], vital signs, and clinical laboratory results at screening).
- The subject was able to understand the nature of the study and any potential hazards associated with participating in it.
- The subject was able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study.
Show all 9Show fewer
- The subject was willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided, and has had the opportunity to discuss the study with the investigator or designee.
- Negative pregnancy test for female subjects. Women of child bearing potential and Women not of child bearing potential were eligible to participate. Both women of child bearing potential and women of no child bearing potential used an approved method of birth control and agrees to continue to use this method for the duration of the study (and for 90 days after taking the last dose of EI1071). Acceptable methods of contraception included abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method, female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner was surgically sterile or 2 years post-menopausal. All male subjects/partners must agree to consistently and correctly use a condom. In addition, subjects may not donate sperm for the duration of the study and for 90 days after taking study drug.
- Subject was currently not using strong inhibitors or inducers of CYP3A4 and was not anticipated to use these for the duration of the study
Who cannot join
- Subjects were eligible for enrollment in the study only if they meet none of the following criteria:
- The subject had a history of severe allergic or anaphylactic reactions.
- The subject had a known allergy or hypersensitivity to any component of the formulation.
- The subject had a medical history or current evidence of any clinically significant (as determined by the investigator) cardiac, endocrine (including diabetes), hematologic, hepatobiliary (abnormal alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transpeptidase [GGT], or total bilirubin), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal condition, or other major disease.
- The subject had a history of any malignant disease.
- The subject had a history of more than one herpes zoster episode or multidermatomal herpes zoster.
Show all 26Show fewer
- The subject had a history of an opportunistic infection (e.g. cytomegalovirus, pneumocystis carinii, aspergillosis, clostridium difficile).
- The subject had a history of or ongoing chronic or recurrent infectious disease (e.g. infected indwelling prosthesis, osteomyelitis, chronic sinusitis).
- The subject had major trauma or surgery in the 2 months before screening or at any time between screening and check-in.
- The subject had an acute infection within 2 weeks before screening or at any time between screening and check-in including, but not limited to, history, signs, or symptoms of a common cold (eg, mild rhinorrhea), untreated oral/dental abnormalities (e.g. untreated dental caries as determined by examination of the mouth), or untreated disruption of the skin.
- The subject had clinically significant abnormal ECG findings at screening, check-in visits, or predose, as determined by the Investigator.
- The subject had a supine blood pressure measurement outside the ranges of 90 to 140 mm Hg systolic or 45 to 90 mm Hg diastolic (measured after a rest of at least 5 minutes) at screening, check-in, or predose. Note: If either value was out of the range, blood pressure measurements may be repeated in the supine position at intervals of 5 to 10 minutes up to 3 times. If the mean systolic or diastolic measurement continues to exceed the stated limits, the subject will be excluded.
- The subject had a pulse of fewer than 45 beats per minute (bpm) or greater than 100 bpm(measured after a rest of at least 5 minutes) at screening, check-in, or predose.
- The subject tests positive for tuberculosis (TB) at screening by the QuantiFERON-TB Gold Test, or has a history of latent, inadequately treated, or active TB.
- The subject had a known history of, or a positive test result for, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) types 1 or 2 at screening.
- The subject had used prescription or over-the-counter (OTC) medication (other than ≤2 g/day paracetamol [acetaminophen] or ≤800 mg/day ibuprofen), vitamins, or herbal remedies, within 2 weeks or 5 half-lives before study drug administration, whichever was longer.
- The subject had participated in another clinical study of a new investigational drug or has received an investigational drug within the 3 months or 5 half-lives (if available) before study drug administration, whichever is longer.
- The subject had a loss of more than 400 mL of blood (e.g. a blood donation) within 2 months before study drug administration, or has received any blood, plasma, or platelet transfusions within 3 months before check-in, or plans to donate blood during the study or within 3 months after the study.
- The subject had a history of alcohol abuse (defined as an alcohol intake more than 21 units per week) or a history of drug abuse within the 6 months before study drug administration, or a history of substance abuse deemed significant by the investigator. A unit of alcohol is defined as 240 mL of beer, 120 mL of wine, or 1 single shot of spirits. The subject will be required to abstain from alcohol consumption 48 hours prior to screening or check-in.
- The subject was a current smoker or has a history of smoking.
- The subject had a positive test for alcohol or drugs of abuse (barbiturates, methamphetamine, benzodiazepines, morphine/opiates, phencyclidine (PCP), amphetamines, tetrahydrocannabinol (THC), methylenedioxymethamphetamine (MDMA), cocaine, methadone, and cotinine) at screening or check-in.
- The subject was unable to participate in, or successfully complete, the study, in the opinion of their general practitioner or the investigator, because the subject was any of the following:
- mentally or legally incapacitated, or unable to give consent for any reason
- in custody due to an administrative or a legal decision, or under tutelage, or being admitted to a sanitarium or social institution
- unable to be contacted in case of emergency
- unlikely to cooperate or comply with the clinical study protocol or was unsuitable for any other reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel Early Phase Clinical Unit
Baltimore, Maryland, 21225
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study Followed by a Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EI1071 in Healthy Volunteers
This was a first-in-human study to determine the safety, tolerability, and pharmacokinetics of EI1071 after single and multiple doses in healthy volunteers.
Read the detailed description
This phase 1 first-in-human study was designed to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of EI1071 when administered to healthy adult volunteers. This was a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort trial. The study was conducted in two phases: a single ascending dose (SAD) phase, followed by a multiple ascending dose (MAD) phase. Approximately 58 healthy volunteers enrolled in SAD and MAD cohorts (34 in SAD; 24 in MAD). In SAD, participants in Cohorts 1 to 5 received one dose of EI-1071 or placebo. In MAD, participants in Cohorts 1 and 2 received multiple doses of EI-1071 or placebo for 14 consecutive days. Safety, tolerability, and PK profile of EI-1071 were assessed.
- Conditions
- Healthy Volunteers
- Being tested
- EI-1071, Placebo
- Keywords
- CSF1R Inhibitor, Safety, Tolerability, Pharmacokinetics, EI1071
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EI-1071Drug
EI-1071 Tablet(s)
PlaceboDrug
Matching Placebo Tablet(s)
| Study group | Role | What they receive |
|---|---|---|
| EI-1071 Tablet | Experimental | EI-1071 tablet(s) administered orally as single ascending dose(SAD), multiple ascending daily dose(MAD) Receives: Drug: EI-1071 |
| Placebo | Placebo comparator | EI-1071 tablet(s) administered orally as single ascending dose(SAD), multiple ascending daily dose(MAD) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
After single ascending doses, number of subjects with treatment-emergent adverse events (TEAEs) after dosing with EI-1071
Experience at least 1 treatment-emergent adverse event
Measured: Up to 7 days
After multiple ascending doses, number of subjects with TEAEs after dosing with EI-1071
Experienced at least 1 treatment-emergent adverse event
Measured: Up to 21 days
After multiple ascending doses, number of subjects with adverse events (AEs) leading to discontinuation in the EI-1071 cohorts.
Discontinued due to adverse event
Measured: Up to 14 days
Secondary outcomes (7)
Cmax
Maximum observed serum concentration
Measured: Single dose: up to 48 hours; Multiple dose: up to 16 days
Tmax
Time to reach Cmax
Measured: Single dose: up to 48 hours; Multiple dose: up to 16 days
t1/2
Terminal half-life
Measured: Single dose: up to 48 hours; Multiple dose: up to 16 days
AUC-last
Area under the curve from the time of dosing to the time of the last measurable concentration
Measured: Single dose: up to 48 hours; Multiple dose: up to 16 days
AUC-inf
Area under the curve from the time of dosing extrapolated to infinity
Measured: Single dose: up to 48 hours; Multiple dose: up to 16 days
Colony Stimulating Factor 1 (CSF1) concentration in blood after multiple-dose administration
Amount of Colony Stimulating Factor 1
Measured: Up to 15 days
Monocyte count in blood after multiple-dose administration
Count of monocyte subsets
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start27 Dec 2019
- Primary completion16 Dec 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elixiron Immunotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Chi-Yun Pai, Study director, Elixiron Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238364
- Sponsor's protocol ID
- EI1071-001
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2020
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study Followed by a Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EI1071 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04238364
- Acronym / sponsor ID
- EI1071-001
- Conditions
- Healthy Volunteers
- Keywords
- CSF1R Inhibitor, Safety, Tolerability, Pharmacokinetics, EI1071
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Elixiron Immunotherapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 23 Jan 2020 (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 was a first-in-human study to determine the safety, tolerability, and pharmacokinetics of EI1071 after single and multiple doses in healthy volunteers.
Detailed description
This phase 1 first-in-human study was designed to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of EI1071 when administered to healthy adult volunteers. This was a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort trial. The study was conducted in two phases: a single ascending dose (SAD) phase, followed by a multiple ascending dose (MAD) phase. Approximately 58 healthy volunteers enrolled in SAD and MAD cohorts (34 in SAD; 24 in MAD). In SAD, participants in Cohorts 1 to 5 received one dose of EI-1071 or placebo. In MAD, participants in Cohorts 1 and 2 received multiple doses of EI-1071 or placebo for 14 consecutive days. Safety, tolerability, and PK profile of EI-1071 were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EI-1071 Tablet | Experimental | Drug: EI-1071EI-1071 tablet(s) administered orally as single ascending dose(SAD), multiple ascending daily dose(MAD) |
| Placebo | Placebo comparator | Drug: PlaceboEI-1071 tablet(s) administered orally as single ascending dose(SAD), multiple ascending daily dose(MAD) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects were eligible for enrollment in the study only if they met all the following criteria:
- Healthy male and female subjects, 18 to 45 years of age, inclusive. (Taiwan only: To be at least 20 years of age.)
- The subject had a body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and weighs at least 50kg.
- The subject was in good health and has no medical condition of clinical significance or that may impact the outcome of the study, as determined by the investigator (as determined by medical history, physical examination, 12-lead electrocardiogram [ECG], vital signs, and clinical laboratory results at screening).
- The subject was able to understand the nature of the study and any potential hazards associated with participating in it.
Key exclusion criteria (26 listed)
- Subjects were eligible for enrollment in the study only if they meet none of the following criteria:
- The subject had a history of severe allergic or anaphylactic reactions.
- The subject had a known allergy or hypersensitivity to any component of the formulation.
- The subject had a medical history or current evidence of any clinically significant (as determined by the investigator) cardiac, endocrine (including diabetes), hematologic, hepatobiliary (abnormal alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transpeptidase [GGT], or total bilirubin), immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal condition, or other major disease.
- The subject had a history of any malignant disease.
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(s) | Drug | EI-1071 Tablet |
| PlaceboMatching Placebo Tablet(s) | Drug | Placebo |
Primary outcome
After single ascending doses, number of subjects with treatment-emergent adverse events (TEAEs) after dosing with EI-1071
Time frame: Up to 7 days
Experience at least 1 treatment-emergent adverse event
After multiple ascending doses, number of subjects with TEAEs after dosing with EI-1071
Time frame: Up to 21 days
Experienced at least 1 treatment-emergent adverse event
After multiple ascending doses, number of subjects with adverse events (AEs) leading to discontinuation in the EI-1071 cohorts.
Time frame: Up to 14 days
Discontinued due to adverse event
7 secondary outcomes
Cmax
Time frame: Single dose: up to 48 hours; Multiple dose: up to 16 days
Tmax
Time frame: Single dose: up to 48 hours; Multiple dose: up to 16 days
t1/2
Time frame: Single dose: up to 48 hours; Multiple dose: up to 16 days
AUC-last
Time frame: Single dose: up to 48 hours; Multiple dose: up to 16 days
AUC-inf
Time frame: Single dose: up to 48 hours; Multiple dose: up to 16 days
Colony Stimulating Factor 1 (CSF1) concentration in blood after multiple-dose administration
Time frame: Up to 15 days
Monocyte count in blood after multiple-dose administration
Time frame: Up to 15 days
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 9 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
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.
Chi-Yun Pai study director
Elixiron Inc.
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 Healthy Volunteers, run by Elixiron Immunotherapeutics Inc. 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 9 inclusion and 26 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 9 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?
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?
After single ascending doses, number of subjects with treatment-emergent adverse events (TEAEs) after dosing with EI-1071 (time frame: Up to 7 days). The study lists 3 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 9 Jun 2026.