Phase
Condition
Allergy
Allergies & Asthma
Allergy (Pediatric)
Treatment
Placebo
KP001
Clinical Study ID
Ages 18-45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Males or females, non-smoker (no use of tobacco or nicotine products within 3 monthsprior to screening), aged ≥ 18 to ≤ 45 years.
A Body Mass Index (BMI) ≥18.5 and ≤ 30 kg/m^2, with body weight, ≥ 50.0 kg for malesand ≥ 45.0 kg for females.
Healthy as defined by a) the absence of clinically significant illness and surgerywithin 4 weeks prior to study drug administration. b) the absence of clinicallysignificant history of neurological, endocrine, cardiovascular, respiratory,hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, andmetabolic disease.
Normal lung function measured by spirometry.
Demonstrated ability to successfully complete pressurized metered dose inhaler (pMDI) training.
Demonstrated ability to successfully hold their breath for a minimum of 30 seconds.
Exclusion
Key Exclusion Criteria:
Positive urine drug screen, urine cotinine test, or alcohol breath test, atscreening.
Known reaction or sensitivity to sympathomimetic amines, or idiosyncratic reactionto epinephrine or any of the ingredients of KP001, placebo.
History of anaphylaxis or other severe allergic reactions (e.g., angioedema)
Surgical procedures within 90 days of admission that could result in confounding ofresults or additional risk to the subject, per the judgment of the Investigator.
History or presence of alcohol abuse or drinking more than 2 standard drinks perday/10 standard drinks per week for women or 3 standard drinks per day/15 standarddrinks per week for men; or a positive alcohol breath test at screening oradmission.
History or presence of drug abuse/dependence (not including nicotine and caffeine)within the previous 1 year or a positive urine drug test at screening or admission.
Use of any tobacco or nicotine-containing products within 3 months prior toscreening.
Use of any inhaled products, including vaping and water pipes (Hookahs) within 6months prior to screening.
Use of any prescription medications within 14 days prior to admission, orover-the-counter medications (including herbal remedies and supplements) within 7days prior to admission, with the exception of the occasional use of acetaminophen (up to 2 g daily), or an anticipated need to use them during the study.
A depot injection or implant of any drug (other than hormonal contraceptives) within 3 months prior to dosing.
Monoamine oxidase (MAO) inhibitors within 30 days prior to dosing.
Positive test for human immunodeficiency virus (HIV), hepatitis C virus (HCV), orhepatitis B virus (HBsAg) at screening.
Abnormal clinical laboratory findings, vital signs, or ECG
Females who are pregnant or lactating, or who have a positive pregnancy test atscreening or admission.
Donated plasma within 7 days prior to screening, or donation or loss of whole blood (excluding the volume drawn during screening for this study) as follows: 50 to 499mL of whole blood within 30 days prior to screening, or ≥ 500 mL of whole bloodwithin 56 days prior to screening.
Participation in another clinical study involving an investigational drug within 30days prior to screening, an investigational biologic within 90 days prior toscreening, or current/planned participation in another interventional study duringthis study.
Study Design
Study Description
Connect with a study center
Syneos HealthClinique Inc.
Quebec City, Quebec G1P 0A2
CanadaActive - Recruiting
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