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This Phase 1a Study Will Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Relative Bioavailability of Single-dose DMI019 Nasal Spray in Healthy Participants.

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This Phase 1a, single-center, randomized study will evaluate the safety, tolerability, pharmacokinetics, and relative bioavailability of single-dose DMI019 nasal spray in healthy participants. Approximately 48 healthy male and female participants will be enrolled. The study includes an open-label, two-period crossover part comparing DMI019 nasal spray with oral emedastine difumarate sustained-release capsules, and a double-blind, placebo-controlled, dose-escalation part evaluating three dose levels of DMI019 nasal spray.
Trial Details
NCT Number NCT07833072
Lead Sponsor The Third Xiangya Hospital of Central South University
Conditions
(from sponsor)		 Healthy Volunteers
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov