A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers

NCT04238364 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: EI1071-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

CSF1R Inhibitor; Safety; Tolerability; Pharmacokinetics; EI1071

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Up to 14 days

Secondary Outcomes (7)

• Cmax

  Single dose: up to 48 hours; Multiple dose: up to 16 days

• Tmax

  Single dose: up to 48 hours; Multiple dose: up to 16 days

• t1/2

  Single dose: up to 48 hours; Multiple dose: up to 16 days

• AUC-last

  Single dose: up to 48 hours; Multiple dose: up to 16 days

• AUC-inf

  Single dose: up to 48 hours; Multiple dose: up to 16 days

Study Arms (2)

EI-1071 Tablet

EXPERIMENTAL

EI-1071 tablet(s) administered orally as single ascending dose(SAD), multiple ascending daily dose(MAD)

Drug: EI-1071

Placebo

PLACEBO COMPARATOR

EI-1071 tablet(s) administered orally as single ascending dose(SAD), multiple ascending daily dose(MAD)

Drug: Placebo

Interventions

EI-1071 DRUG

EI-1071 Tablet(s)

EI-1071 Tablet

Placebo DRUG

Matching Placebo Tablet(s)

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Elixiron Immunotherapeutics (Hong Kong) Ltd.: lead
• Parexel: collaborator

Study Sites (1)

Parexel Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Location

Study Officials

• Chi-Yun Pai

  Elixiron Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 23, 2020
• Study Start: December 27, 2019
• Primary Completion: December 16, 2021
• Study Completion: January 10, 2022
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)