Summary:
- ARS Pharmaceuticals Inc. / “A Two-Treatment, Sequential Crossover Study of the Pharmacokinetics of Adrenaline After Administration of ARS-1 in Subjects with Upper Respiratory Tract Infection (Infectious Rhinitis)”
- The study required an overnight stay with 2 intervals of at least 7 days apart.
Inclusion Criteria:
- Is a male or female subject between the ages of 18 and 55 years, inclusive
- Subject has symptoms of an URTI (congestion/stuffiness, runny nose, sneezing, itching) at time of screening and dosing.
- Has body weight more than 55 kg for male and 50 kg for female and body mass index between 18 and 32 kg/m², inclusive.
- Is a nonsmoker within the previous 2 months (calculated from first dosing) and does not use tobacco-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing nicotine, or nicotine patch or gum).
Exclusion Criteria:
- Has current or past history of clinically significant asthma or angioedema.
- Has prior nasal fractures, severe nasal injuries or history of nasal disorders (e.g., polyps, polyposis, recurrent epistasis [>1 nose bleed per month], deviated septum, nasal piercing or any nasal passage abnormality that could interfere with nasal spray administration, abuse of nasal decongestants, or sleep apnea) that could interfere with nasal spray administration.
- Has had treatment with any adrenaline or noradrenaline containing products within 7 days of Day 0.
- Has inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.
Qualified Participants May Receive:
- Compensation up to $1,200.00
- Study Traement and Physical Exam or Assessments