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NOT YET RECRUITING
NCT07903337
PHASE1

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

Sponsor: Elixiron Immunotherapeutics Inc.

View on ClinicalTrials.gov

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. Stage 2 study may be conducted based on the results of Stage 1 study.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-11

Completion Date

2027-08

Last Updated

2026-10-29

Healthy Volunteers

Yes

Interventions

DRUG

EI-1071

EI-1071 tablet, oral

Locations (1)

Taipei Medical University Hospital

Taipei, Taiwan