Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Asmacure Ltée
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Able and willing to provide written informed consent.
Male or female subjects, ≥ 18 years and ≤ 55 years of age
Diagnosis of moderate asthma and on regular inhaled corticosteroids with or without short or long-acting Beta-2-agonists
FEV1 ≥ 55 % predicted in the absence of medications for asthma
Female subjects of childbearing potential must have a negative pregnancy test (serum beta-human chorionic gonadotropin (b-HCG)) at Screening, and a negative pregnancy test immediately before the administration of the study drug for each of Periods 1, 2 and 3. Sexually active females with non-sterile partner must be willing to use adequate contraception.
Male subjects must be willing to use a condom with a spermicide for the duration of their participation in the study, plus an additional 30 days following study drug administration and ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an intra-uterine device (IUD). Male subjects must ensure that their female partner is willing to use adequate contraception.
Demonstration of an increase in FEV1 by ≥ 10 % predicted between spirometry performed before and 10-20 minutes after the administration of 2 puffs of 100 micrograms of salbutamol at Screening.
You may not be if
Clinically significant conditions or illnesses other than moderate asthma or systemic diseases
Pregnant or nursing women or women intending to conceive during the course of the study or have a positive serum pregnancy test at Screening or a positive urine pregnancy test during the study.
Women of childbearing potential (unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years) not using a highly effective method of birth control.
Non-surgically sterile males and males with partners of childbearing potential not willing to use a condom with spermicide for the duration of their participation in the study plus an additional 30 days following study drug administration and to ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an IUD.
Respiratory tract infections or worsening of asthma or changes in asthma medications within 6 weeks before Screening/Baseline.
Current cigarette smokers or former smokers with a smoking history of greater than 10 pack years or who stopped smoking within 12 months preceding enrolment in the study.
Positive urine cotinine test at Screening.
History of illicit drug use or alcohol abuse within 12 months before Screening.
Positive test for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV) at Screening.
Any medication that are known to prolong QT / QTc interval.
Any of the following concomitant medications preceding the administration of salbutamol during Screening and preceding the administration of the study drug:
* Oral or i.v. corticosteroids within 1 month;
* Inhaled or intranasal corticosteroids within 48 hours;
* Long acting Beta-2-agonists within 24 hours;
* Short acting Beta-2-agonists within 8 hours;
* Anticholinergic aerosols within 24 hours; and
* Theophylline-containing products within 48 hours.
Use of NSAIDs within 7 days preceding the administration of salbutamol during Screening and throughout the study.
Use of antihistaminic drugs within 3 days preceding the administration of salbutamol during Screening.
Use of an investigational product or participation in a clinical trial using an investigational product within 30 days before dosing or within 90 days in the case of long-acting products (ex.: Depo-medrol) or biologics with a long-acting half-life (ex.: monoclonal antibodies).
Clareo Health | Safety, Tolerability and Clinical Activity of ASM-024 in Stable Moderate Asthma
