Healthy VolunteersPhase 1NCT07833072
This Phase 1a Study Will Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Relative Bioavailability of Single-dose DMI019 Nasal Spray in Healthy Participants.
A Phase 1 study testing DMI019 Nasal Spray 0.4 mg, Emedastine Difumarate Sustained-Release Capsule 2 mg and DMI019 Nasal Spray 0.8 mg in people with Healthy Volunteers, run by The Third Xiangya Hospital of Central South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- DMI019 Nasal Spray 0.4 mg, Emedastine Difumarate Sustained-Release Capsule 2 mg and DMI019 Nasal Spray 0.8 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Participants who are able to communicate effectively with the investigator, correctly use the nasal spray device after training, and understand and comply with all study requirements.
Who cannot join
- 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.
- A history of hypertension or hypotension, including orthostatic hypotension.
- A clinically significant nasal medical history, disease, or abnormality that, in the investigator's judgment, may affect administration or absorption of the study intervention, including:
Show all 23Show fewer
- A history of persistent nasal congestion, rhinorrhea, epistaxis, or similar symptoms;
- A history of nasal surgery, nasal trauma, severe rhinitis, or severe sinusitis that may affect drug absorption;
- Any other structural abnormality of the nasal cavity or abnormality of the nasal mucosa that may affect drug absorption.
- Major surgery within 6 months before screening or planned surgery during the study, except for appendectomy or hernia repair.
- Clinically significant abnormalities identified at screening through physical examination, vital signs, 12-lead electrocardiogram, posteroanterior chest X-ray, or laboratory testing, including hematology, urinalysis, serum chemistry, coagulation tests, or testing for transfusion-transmitted infections. This includes alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase above the upper limit of normal; total bilirubin greater than 1.2 times the upper limit of normal; or serum creatinine greater than 1.2 times the upper limit of normal.
- Uncontrolled ventricular arrhythmia at screening; corrected QT interval using Fridericia's formula (QTcF) of at least 450 milliseconds in male participants or at least 460 milliseconds in female participants; a history of long QT syndrome; or any concomitant condition that may prolong the QT interval.
- Consumption of more than 5 cups per day of tea, coffee, or other caffeine-containing beverages within 3 months before screening, with each cup defined as approximately 200 mL.
- Consumption within 48 hours before the first administration of the study intervention of a special diet or products that may affect drug absorption, distribution, metabolism, or excretion, including grapefruit or grapefruit-containing products, chocolate, caffeine-containing products, or foods rich in xanthines such as animal liver; strenuous exercise during this period; or any other factor that may affect drug pharmacokinetics.
- Use within 30 days before the first administration of the study intervention of any drug known to induce or inhibit hepatic drug metabolism. Examples include inducers such as barbiturates, carbamazepine, phenytoin, glucocorticoids, and omeprazole, and inhibitors such as selective serotonin reuptake inhibitors, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, and antihistamines.
- Pregnant or breastfeeding women.
- Use of any prescription drug, over-the-counter drug, traditional Chinese medicine, herbal product, dietary supplement, or health product within 14 days before the first administration of the study intervention.
- Habitual smoking, smoking at least 5 cigarettes per day within 3 months before screening, a positive nicotine test at screening, or inability to abstain from smoking throughout the study.
- Consumption of more than 14 standard units of alcohol per week within 6 months before screening, where one standard unit contains 14 g of alcohol and is approximately equivalent to 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine; a positive alcohol breath test before the first administration of the study intervention; or inability to abstain from alcohol throughout the study.
- A history of drug abuse within 1 year before screening, including abuse of cannabis, benzodiazepines, ketamine, morphine, cocaine, methamphetamine, barbiturates, or tricyclic antidepressants, or a positive urine drug screen.
- Participation in another clinical study involving administration of an investigational drug or use of an investigational device within 3 months before screening.
- Donation or loss of at least 400 mL of blood within 3 months before screening; planned donation of blood or blood components during the study or within 3 months after study completion; receipt of a live attenuated vaccine within 28 days before the first administration of the study intervention; receipt of an inactivated vaccine within 14 days before the first administration; or planned vaccination during the study.
- Any other medical or psychological condition that, in the investigator's judgment, may expose the participant to excessive risk, interfere with compliance with the protocol, or affect the participant's ability to complete the study.
About this study
Official title: A Study of the Safety, Tolerability, and Pharmacokinetics of Single-Dose DMI019 Nasal Spray in Healthy Participants
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.
Read the detailed description
This is a Phase 1a, single-center, randomized, single-dose study in approximately 48 healthy male and female participants. The primary objective is to evaluate the safety and tolerability of DMI019 nasal spray following a single dose. The secondary objectives are to characterize the pharmacokinetics of emedastine and to evaluate the relative bioavailability of DMI019 nasal spray compared with oral emedastine difumarate sustained-release capsules.The study consists of four cohorts: Part A and Cohorts B, C, and D.Part A will enroll approximately 12 participants and will use a randomized, open-label, two-period, two-sequence crossover design. Participants will be randomized in a 1:1 ratio to the TR or RT treatment sequence. In separate treatment periods, each participant will receive a single intranasal dose of DMI019 nasal spray 0.4 mg and a single oral dose of emedastine difumarate sustained-release capsule 2 mg under fasting conditions. The two treatment periods will be separated by a 7-day washout period. Part A will assess the relative bioavailability and pharmacokinetic profiles of the two formulations.Cohorts B, C, and D will enroll approximately 36 participants, with 12 participants in each cohort. These cohorts will use a randomized, double-blind, placebo-controlled, parallel-group, sequential dose-escalation design. Within each cohort, participants will be randomized in a 5:1 ratio to receive a single intranasal dose of DMI019 nasal spray or matching placebo under fasting conditions. The planned DMI019 dose levels are 0.8 mg in Cohort B, 1.6 mg in Cohort C, and 2.4 mg in Cohort D. Dose escalation to the next cohort will occur only after the available safety, tolerability, and pharmacokinetic data from the preceding cohort have been reviewed by the investigator and sponsor and no unacceptable safety risk has been identified.Blood samples for pharmacokinetic analysis will be collected before dosing and for up to 48 hours after dosing. Pharmacokinetic parameters will include maximum observed plasma concentration, time to maximum plasma concentration, area under the plasma concentration-time curve, terminal elimination rate constant, terminal elimination half-life, apparent clearance, apparent volume of distribution, mean residence time, and other relevant parameters.Safety and tolerability will be evaluated based on adverse events, vital signs, physical examinations, nasal examinations, clinical laboratory tests, and 12-lead electrocardiograms. Participants with unresolved adverse events will be followed until the event has resolved, stabilized, or received an adequate clinical explanation.
- Conditions
- Healthy Volunteers
- Being tested
- DMI019 Nasal Spray 0.4 mg, Emedastine Difumarate Sustained-Release Capsule 2 mg, DMI019 Nasal Spray 0.8 mg, DMI019 Nasal Spray 1.6 mg, DMI019 Nasal Spray 2.4 mg
- Keywords
- DMI019, Emedastine, Nasal Spray, Intranasal Administration, Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMI019 Nasal Spray 0.4 mgDrug
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.
Emedastine Difumarate Sustained-Release Capsule 2 mgDrug
A single 2 mg emedastine difumarate sustained-release capsule will be administered orally under fasting conditions.
DMI019 Nasal Spray 0.8 mgDrug
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.
DMI019 Nasal Spray 1.6 mgDrug
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.
DMI019 Nasal Spray 2.4 mgDrug
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.
DMI019 Nasal Spray PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Part A: TR Sequence | Experimental | Participants will receive a single intranasal dose of DMI019 nasal spray 0.4 mg under fasting conditions in Period 1, followed by a 7-day washout period, and then a single oral dose of emedastine difumarate sustained-release capsule 2 mg under fasting conditions in Period 2. Receives: Drug: DMI019 Nasal Spray 0.4 mg; Drug: Emedastine Difumarate Sustained-Release Capsule 2 mg |
| Part A: RT Sequence | Experimental | Participants will receive a single oral dose of emedastine difumarate sustained-release capsule 2 mg under fasting conditions in Period 1, followed by a 7-day washout period, and then a single intranasal dose of DMI019 nasal spray 0.4 mg under fasting conditions in Period 2. Receives: Drug: DMI019 Nasal Spray 0.4 mg; Drug: Emedastine Difumarate Sustained-Release Capsule 2 mg |
| Part B: DMI019 Nasal Spray 0.8 mg | Experimental | Participants will receive a single intranasal dose of DMI019 nasal spray 0.8 mg under fasting conditions. The dose will be administered as four sprays of the 0.2 mg/spray formulation, with two sprays administered into each nostril and an interval of approximately 30 seconds between consecutive sprays into the same nostril. Receives: Drug: DMI019 Nasal Spray 0.8 mg |
| Part B: Placebo | Placebo comparator | Participants will receive a single intranasal dose of matching DMI019 nasal spray placebo under fasting conditions according to the administration schedule used for Part B. Receives: Drug: DMI019 Nasal Spray Placebo |
| Part C: DMI019 Nasal Spray 1.6 mg | Experimental | Participants will receive a single intranasal dose of DMI019 nasal spray 1.6 mg under fasting conditions. The dose will be administered as four sprays of the 0.4 mg/spray formulation, with two sprays administered into each nostril and an interval of approximately 30 seconds between consecutive sprays into the same nostril. Receives: Drug: DMI019 Nasal Spray 1.6 mg |
| Part C: Placebo | Placebo comparator | Participants will receive a single intranasal dose of matching DMI019 nasal spray placebo under fasting conditions according to the administration schedule used for Part C. Receives: Drug: DMI019 Nasal Spray Placebo |
| Part D: DMI019 Nasal Spray 2.4 mg | Experimental | Participants will receive a single intranasal dose of DMI019 nasal spray 2.4 mg under fasting conditions. The dose will be administered as six sprays of the 0.4 mg/spray formulation, with three sprays administered into each nostril and an interval of approximately 30 seconds between consecutive sprays into the same nostril. Receives: Drug: DMI019 Nasal Spray 2.4 mg |
| Part D: Placebo | Placebo comparator | Participants will receive a single intranasal dose of matching DMI019 nasal spray placebo under fasting conditions according to the administration schedule used for Part D. Receives: Drug: DMI019 Nasal Spray Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From screening through approximately 48 hours after the final study dose.
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.
Measured: From signing informed consent through Day 11 for Part A and through Day 7 for Parts B-D; unresolved adverse events will be followed until resolution, stabilization, or adequate clinical explanation.
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.
Measured: From screening through the end-of-study assessment, approximately 48 hours after the final study dose.
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.
Measured: From screening through the end-of-study assessment, approximately 48 hours after the final study dose.
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Clinical laboratory evaluations will include hematology, urinalysis, serum chemistry, and coagulation tests. The number of participants with clinically significant post-baseline abnormalities, shifts from normal to abnormal, or worsening of pre-existing abnormalities will be summarized by treatment and dose group.
Measured: From screening through the end-of-study assessment, approximately 48 hours after the final study dose.
Number of Participants With Clinically Significant Twelve-Lead Electrocardiogram Abnormalities
The number and percentage of participants with clinically significant abnormalities or worsening from baseline in twelve-lead electrocardiogram findings will be summarized by treatment group. Each participant will be counted once if at least one clinically significant electrocardiogram abnormality is identified.
Measured: From screening through 48 hours after the final study dose.
Secondary outcomes (12)
Maximum Observed Plasma Concentration of Emedastine
Maximum observed plasma concentration of emedastine following administration of the study intervention.
Measured: Pre-dose through 48 hours after dosing.
Time to Maximum Observed Plasma Concentration of Emedastine
Time at which the maximum observed plasma concentration of emedastine is reached.
Measured: Pre-dose through 48 hours after dosing.
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.
Measured: Pre-dose through 48 hours after dosing.
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.
Measured: Pre-dose through 48 hours after dosing.
Percentage of AUC Extrapolated From the Last Quantifiable Concentration to Infinity
Percentage of the total area under the plasma concentration-time curve that is extrapolated from the last quantifiable concentration to infinity.
Measured: Pre-dose through 48 hours after dosing.
Time of the Last Quantifiable Plasma Concentration of Emedastine
Time at which the last quantifiable plasma concentration of emedastine is observed.
Measured: Pre-dose through 48 hours after dosing.
Terminal Elimination Rate Constant of Emedastine
Terminal elimination rate constant of emedastine estimated from the terminal log-linear portion of the plasma concentration-time profile.
Measured: Pre-dose through 48 hours after dosing.
Terminal Elimination Half-Life of Emedastine
Time required for the plasma concentration of emedastine to decrease by 50% during the terminal elimination phase.
Measured: Pre-dose through 48 hours after dosing.
Apparent Total Clearance of Emedastine
Apparent total clearance of emedastine from plasma after extravascular administration.
Measured: Pre-dose through 48 hours after dosing.
Apparent Volume of Distribution During the Terminal Phase
Apparent volume of distribution of emedastine during the terminal elimination phase after extravascular administration.
Measured: Pre-dose through 48 hours after dosing.
Mean Residence Time of Emedastine
Mean time that emedastine molecules remain in the body following administration of the study intervention.
Measured: Pre-dose through 48 hours after dosing.
Relative Bioavailability of DMI019 Nasal Spray Compared With Emedastine Difumarate Sustained-Release Capsule
Relative bioavailability of emedastine following a single intranasal dose of DMI019 nasal spray 0.4 mg compared with a single oral dose of emedastine difumarate sustained-release capsule 2 mg in Part A.
Measured: Pre-dose through 48 hours after dosing in each treatment period of Part A.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoping Yang, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833072
- Sponsor's protocol ID
- DMI019-E-01
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety, Tolerability, and Pharmacokinetics of Single-Dose DMI019 Nasal Spray in Healthy Participants
- ClinicalTrials.gov ID
- NCT07833072
- Acronym / sponsor ID
- DMI019-E-01
- Conditions
- Healthy Volunteers
- Keywords
- DMI019, Emedastine, Nasal Spray, Intranasal Administration, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1a, single-center, randomized, single-dose study in approximately 48 healthy male and female participants. The primary objective is to evaluate the safety and tolerability of DMI019 nasal spray following a single dose. The secondary objectives are to characterize the pharmacokinetics of emedastine and to evaluate the relative bioavailability of DMI019 nasal spray compared with oral emedastine difumarate sustained-release capsules.The study consists of four cohorts: Part A and Cohorts B, C, and D.Part A will enroll approximately 12 participants and will use a randomized, open-label, two-period, two-sequence crossover design. Participants will be randomized in a 1:1 ratio to the TR or RT treatment sequence. In separate treatment periods, each participant will receive a single intranasal dose of DMI019 nasal spray 0.4 mg and a single oral dose of emedastine difumarate sustained-release capsule 2 mg under fasting conditions. The two treatment periods will be separated by a 7-day washout period. Part A will assess the relative bioavailability and pharmacokinetic profiles of the two formulations.Cohorts B, C, and D will enroll approximately 36 participants, with 12 participants in each cohort. These cohorts will use a randomized, double-blind, placebo-controlled, parallel-group, sequential dose-escalation design. Within each cohort, participants will be randomized in a 5:1 ratio to receive a single intranasal dose of DMI019 nasal spray or matching placebo under fasting conditions. The planned DMI019 dose levels are 0.8 mg in Cohort B, 1.6 mg in Cohort C, and 2.4 mg in Cohort D. Dose escalation to the next cohort will occur only after the available safety, tolerability, and pharmacokinetic data from the preceding cohort have been reviewed by the investigator and sponsor and no unacceptable safety risk has been identified.Blood samples for pharmacokinetic analysis will be collected before dosing and for up to 48 hours after dosing. Pharmacokinetic parameters will include maximum observed plasma concentration, time to maximum plasma concentration, area under the plasma concentration-time curve, terminal elimination rate constant, terminal elimination half-life, apparent clearance, apparent volume of distribution, mean residence time, and other relevant parameters.Safety and tolerability will be evaluated based on adverse events, vital signs, physical examinations, nasal examinations, clinical laboratory tests, and 12-lead electrocardiograms. Participants with unresolved adverse events will be followed until the event has resolved, stabilized, or received an adequate clinical explanation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part A: TR Sequence | Experimental | Drug: DMI019 Nasal Spray 0.4 mg, Drug: Emedastine Difumarate Sustained-Release Capsule 2 mgParticipants will receive a single intranasal dose of DMI019 nasal spray 0.4 mg under fasting conditions in Period 1, followed by a 7-day washout period, and then a single oral dose of emedastine difumarate sustained-release capsule 2 mg under fasting conditions in Period 2. |
| Part A: RT Sequence | Experimental | Drug: DMI019 Nasal Spray 0.4 mg, Drug: Emedastine Difumarate Sustained-Release Capsule 2 mgParticipants will receive a single oral dose of emedastine difumarate sustained-release capsule 2 mg under fasting conditions in Period 1, followed by a 7-day washout period, and then a single intranasal dose of DMI019 nasal spray 0.4 mg under fasting conditions in Period 2. |
| Part B: DMI019 Nasal Spray 0.8 mg | Experimental | Drug: DMI019 Nasal Spray 0.8 mgParticipants will receive a single intranasal dose of DMI019 nasal spray 0.8 mg under fasting conditions. The dose will be administered as four sprays of the 0.2 mg/spray formulation, with two sprays administered into each nostril and an interval of approximately 30 seconds between consecutive sprays into the same nostril. |
| Part B: Placebo | Placebo comparator | Drug: DMI019 Nasal Spray PlaceboParticipants will receive a single intranasal dose of matching DMI019 nasal spray placebo under fasting conditions according to the administration schedule used for Part B. |
| Part C: DMI019 Nasal Spray 1.6 mg | Experimental | Drug: DMI019 Nasal Spray 1.6 mgParticipants will receive a single intranasal dose of DMI019 nasal spray 1.6 mg under fasting conditions. The dose will be administered as four sprays of the 0.4 mg/spray formulation, with two sprays administered into each nostril and an interval of approximately 30 seconds between consecutive sprays into the same nostril. |
| Part C: Placebo | Placebo comparator | Drug: DMI019 Nasal Spray PlaceboParticipants will receive a single intranasal dose of matching DMI019 nasal spray placebo under fasting conditions according to the administration schedule used for Part C. |
| Part D: DMI019 Nasal Spray 2.4 mg | Experimental | Drug: DMI019 Nasal Spray 2.4 mgParticipants will receive a single intranasal dose of DMI019 nasal spray 2.4 mg under fasting conditions. The dose will be administered as six sprays of the 0.4 mg/spray formulation, with three sprays administered into each nostril and an interval of approximately 30 seconds between consecutive sprays into the same nostril. |
| Part D: Placebo | Placebo comparator | Drug: DMI019 Nasal Spray PlaceboParticipants will receive a single intranasal dose of matching DMI019 nasal spray placebo under fasting conditions according to the administration schedule used for Part D. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- Participants who are able to communicate effectively with the investigator, correctly use the nasal spray device after training, and understand and comply with all study requirements.
Key exclusion criteria (23 listed)
- 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.
- A history of hypertension or hypotension, including orthostatic hypotension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMI019 Nasal Spray 0.4 mgA 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 | Part A: RT Sequence, Part A: TR Sequence |
| Emedastine Difumarate Sustained-Release Capsule 2 mgA single 2 mg emedastine difumarate sustained-release capsule will be administered orally under fasting conditions. | Drug | Part A: RT Sequence, Part A: TR Sequence |
| DMI019 Nasal Spray 0.8 mgA 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 | Part B: DMI019 Nasal Spray 0.8 mg |
| DMI019 Nasal Spray 1.6 mgA 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 | Part C: DMI019 Nasal Spray 1.6 mg |
| DMI019 Nasal Spray 2.4 mgA 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 | Part D: DMI019 Nasal Spray 2.4 mg |
| DMI019 Nasal Spray PlaceboA single dose of matching placebo nasal spray will be administered intranasally under fasting conditions using the administration schedule corresponding to the assigned dose cohort. | Drug | Part B: Placebo, Part C: Placebo, Part D: Placebo |
Primary outcome
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: From screening through approximately 48 hours after the final study dose.
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
Time frame: From signing informed consent through Day 11 for Part A and through Day 7 for Parts B-D; unresolved adverse events will be followed until resolution, stabilization, or adequate clinical explanation.
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
Time frame: From screening through the end-of-study assessment, approximately 48 hours after the final study dose.
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
Time frame: From screening through the end-of-study assessment, approximately 48 hours after the final study dose.
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.
Number of Participants With Clinically Significant Clinical Laboratory Abnormalities
Time frame: From screening through the end-of-study assessment, approximately 48 hours after the final study dose.
Clinical laboratory evaluations will include hematology, urinalysis, serum chemistry, and coagulation tests. The number of participants with clinically significant post-baseline abnormalities, shifts from normal to abnormal, or worsening of pre-existing abnormalities will be summarized by treatment and dose group.
Number of Participants With Clinically Significant Twelve-Lead Electrocardiogram Abnormalities
Time frame: From screening through 48 hours after the final study dose.
The number and percentage of participants with clinically significant abnormalities or worsening from baseline in twelve-lead electrocardiogram findings will be summarized by treatment group. Each participant will be counted once if at least one clinically significant electrocardiogram abnormality is identified.
12 secondary outcomes
Maximum Observed Plasma Concentration of Emedastine
Time frame: Pre-dose through 48 hours after dosing.
Time to Maximum Observed Plasma Concentration of Emedastine
Time frame: Pre-dose through 48 hours after dosing.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration
Time frame: Pre-dose through 48 hours after dosing.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity
Time frame: Pre-dose through 48 hours after dosing.
Percentage of AUC Extrapolated From the Last Quantifiable Concentration to Infinity
Time frame: Pre-dose through 48 hours after dosing.
Time of the Last Quantifiable Plasma Concentration of Emedastine
Time frame: Pre-dose through 48 hours after dosing.
Terminal Elimination Rate Constant of Emedastine
Time frame: Pre-dose through 48 hours after dosing.
Terminal Elimination Half-Life of Emedastine
Time frame: Pre-dose through 48 hours after dosing.
Apparent Total Clearance of Emedastine
Time frame: Pre-dose through 48 hours after dosing.
Apparent Volume of Distribution During the Terminal Phase
Time frame: Pre-dose through 48 hours after dosing.
Mean Residence Time of Emedastine
Time frame: Pre-dose through 48 hours after dosing.
Relative Bioavailability of DMI019 Nasal Spray Compared With Emedastine Difumarate Sustained-Release Capsule
Time frame: Pre-dose through 48 hours after dosing in each treatment period of Part A.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DMI019 Nasal Spray 0.4 mg, Emedastine Difumarate Sustained-Release Capsule 2 mg and DMI019 Nasal Spray 0.8 mg in people with Healthy Volunteers, run by The Third Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinically Significant Changes in Vital Signs (time frame: From screening through approximately 48 hours after the final study dose.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.