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

NCT04238364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-02-25

No results posted yet for this study

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

Interventions

DRUG

EI-1071

EI-1071 Tablet(s)

DRUG

Placebo

Matching Placebo Tablet(s)

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Elixiron Immunotherapeutics (Hong Kong) Ltd.

    lead INDUSTRY

Principal Investigators

  • Chi-Yun Pai · Elixiron Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-27
Primary Completion
2021-12-16
Completion
2022-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04238364 on ClinicalTrials.gov