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NOT YET RECRUITING
NCT07833072
PHASE1

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

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

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.

Official title: A Study of the Safety, Tolerability, and Pharmacokinetics of Single-Dose DMI019 Nasal Spray in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-09-30

Completion Date

2027-07-31

Last Updated

2026-09-22

Healthy Volunteers

Yes

Interventions

DRUG

DMI019 Nasal Spray 0.4 mg

A single 0.4 mg dose of DMI019 nasal spray will be administered intranasally under fasting conditions as two sprays of the 0.2 mg/spray formulation, with one spray administered into each nostril.

DRUG

Emedastine Difumarate Sustained-Release Capsule 2 mg

A single 2 mg emedastine difumarate sustained-release capsule will be administered orally under fasting conditions.

DRUG

DMI019 Nasal Spray 0.8 mg

A single 0.8 mg dose of DMI019 nasal spray will be administered intranasally under fasting conditions as four sprays of the 0.2 mg/spray formulation, with two sprays administered into each nostril.

DRUG

DMI019 Nasal Spray 1.6 mg

A single 1.6 mg dose of DMI019 nasal spray will be administered intranasally under fasting conditions as four sprays of the 0.4 mg/spray formulation, with two sprays administered into each nostril.

DRUG

DMI019 Nasal Spray 2.4 mg

A single 2.4 mg dose of DMI019 nasal spray will be administered intranasally under fasting conditions as six sprays of the 0.4 mg/spray formulation, with three sprays administered into each nostril.

DRUG

DMI019 Nasal Spray Placebo

A single dose of matching placebo nasal spray will be administered intranasally under fasting conditions using the administration schedule corresponding to the assigned dose cohort.