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.
Participants who fully understand the study, voluntarily agree to participate, and provide written informed consent before any study-related procedures are performed.
Chinese male or female participants aged 18 to 45 years, inclusive.
Male participants with a body weight of at least 50.0 kg and female participants with a body weight of at least 45.0 kg, with a body mass index (BMI) of 18.5 to 28.0 kg/m², inclusive.
From the time of signing the informed consent form until 3 months after the last administration of the study intervention, the participant and the participant's partner must have no plans for pregnancy, sperm donation, or egg donation. Participants must agree to use at least one non-pharmacological method of contraception from the time of signing informed consent until the last pharmacokinetic blood sample is collected and to use an effective method of contraception for 3 months after the last administration of the study intervention.
Known hypersensitivity to the study intervention or any of its components, or a history of severe allergic constitution, defined as known allergy to three or more drugs or foods.
Inability to comply with the standardized dietary requirements of the study.
Inability to tolerate venipuncture or a history of fainting associated with needles or blood.
A history or current presence of a clinically significant disease of the cardiovascular, endocrine, neurological, gastrointestinal, respiratory, urinary, ophthalmological, hematological, immunological, psychiatric, or metabolic system, including hypokalemia, atopic allergic disease, psychiatric disorders, or disorders of brain function, that in the investigator's judgment makes the participant unsuitable for the study.
Parallel
DMI019 Nasal Spray 0.4 mg
DrugA 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.
Emedastine Difumarate Sustained-Release Capsule 2 mg
DrugA single 2 mg emedastine difumarate sustained-release capsule will be administered orally under fasting conditions.
DMI019 Nasal Spray 0.8 mg
DrugA 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.
DMI019 Nasal Spray 1.6 mg
DrugA 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.
DMI019 Nasal Spray 2.4 mg
DrugA 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.
DMI019 Nasal Spray Placebo
DrugA single dose of matching placebo nasal spray will be administered intranasally under fasting conditions using the administration schedule corresponding to the assigned dose cohort.
8
Treatment groupsSee each treatment group below.
Number of Participants With Clinically Significant Changes in Vital Signs
Vital sign assessments will include systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature. The number of participants with clinically significant abnormalities or worsening from baseline will be summarized by treatment and dose group.
Incidence and Severity of Adverse Events
The number and percentage of participants with adverse events, treatment-related adverse events, serious adverse events, and treatment-related serious adverse events will be summarized by treatment and dose group. Adverse events will be assessed for severity, seriousness, outcome, and relationship to the study intervention.
Number of Participants With Clinically Significant Physical Examination Abnormalities
Physical examinations will include assessments of the skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, spine and extremities, and nervous system. Clinically significant new abnormalities or worsening of pre-existing findings will be summarized.
Number of Participants With Clinically Significant Nasal Examination Abnormalities
Nasal examinations will be performed to identify clinically significant nasal symptoms, mucosal abnormalities, or other abnormal findings. Instrument-assisted examination using a nasal speculum may be performed when considered necessary.
Maximum Observed Plasma Concentration of Emedastine
Maximum observed plasma concentration of emedastine following administration of the study intervention.
Time to Maximum Observed Plasma Concentration of Emedastine
Time at which the maximum observed plasma concentration of emedastine is reached.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration
Area under the plasma emedastine concentration-time curve from time zero to the time of the last quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity
Area under the plasma emedastine concentration-time curve from time zero extrapolated to infinity.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
