Urticaria
Conditions
Brief summary
Determine the effect of ARS-1 on a patient reported pruritus/hive score
Interventions
DRUGARS-1
A single treatment of ARS-1 1mg, 2 mg or placebo
Sponsors
ARS Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each subject received all three treatments in a randomized sequence.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Male or female subject between the ages of 18 and 65 years. * 2\. Clinically diagnosed urticaria with acute symptom flares at least two (2) times a week while on a chronic treatment. * 3\. Body weight more than 30 kg and body mass index between 18 and 34 kg/m². * 4\. Has no medical history of hypertension and cardiovascular disease in the last 10 years. * 5\. At screening, has stable vital signs. * 6\. If female, is not pregnant or breastfeeding. * 7\. If male (with or without vasectomy), agree to the use of highly effective contraceptive methods at screening until 7 days after the last day of study drug. 8\. Is able to communicate clearly with the Investigator and staff. 9. Provide written informed consent prior to participating in the study.
Exclusion criteria
* 1\. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease. * 2\. Patients receiving beta blocker due to potential interaction with the study drug. * 3\. Prior nasal fractures, severe nasal injuries or history of nasal disorders. * 4\. Clinically significant medical condition or physical exam finding. * 5\. Abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal ECG. * 6\. Mucosal inflammatory disorders. * 7\. Significant traumatic injury or major surgery within 30 days prior to study screening. * 8\. Has donated blood or had an acute loss of blood (\>50 mL) during the 30 days before study drug administration. * 9\. Known hypersensitivity to any compound in the test product. * 10\. Participated in a clinical trial within 30 days prior to the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of ARS-1 Versus Placebo Based on a Patient Reported Pruritus/Hive Score | UAS score at 120 (± 10 min) minutes after dosing. | Assess time to effect and duration of effect on acute flares associated with urticaria based on a patient reported pruritus/hive score, from 0 (none) to 3 (severe) for itch and hive using Uniform Assessment System (UAS) as below: Severity Score Amount of Itch Itch Severity 0 None None 1. Mild Easily tolerated 2. Moderate Bothersome but tolerable 3. Intense Difficult to tolerate Hive Severity Score Number of Hives 0 None 1. 1-6 2. 7-12 3. \>12 |
Countries
United States
Contacts
STUDY_DIRECTORSarina Tanimoto, MD, PhD
ARS Pharmaceuticals, Inc.
Participant flow
Pre-assignment details
Cross-over study. All participants received at least one treatment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 6 / 21 | 7 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 | 0 / 21 |
Outcome results
None listed