None listed
Conditions
Brief summary
This is a research study to evaluate ascending doses and concentrations of Citramel inhalation. It is open label administration of Citramel to three cohorts, each of 5 healthy volunteers, to evaluate safety and tolerability.
Interventions
Cohort 1: Citramel Low Dose - an aqueous solution of sodium citrate (16.18 mg/mL), citric
acid (0.046 mg/mL) and ammonium chloride (4.12 mg/mL).
Cohort 2: Citramel Medium Dose - an aqueous solution of sodium citrate (48.54 mg/mL), citric acid (0.138 mg/mL) and ammonium chloride (12.36 mg/mL).
Cohort 3: Citramel High Dose (if administered) - an aqueous solution of sodium citrate (64.72 mg/mL), citric acid (0.184 mg/mL) and ammonium chloride (16.48 mg/mL).
Administered by aerosol twice daily (
Cohort 1: Citramel Low Dose - an aqueous solution of sodium citrate (16.18 mg/mL), citric acid (0.046 mg/mL) and ammonium chloride (4.12 mg/mL). Cohort 2: Citramel Medium Dose - an aqueous solution of sodium citrate (48.54 mg/mL), citric acid (0.138 mg/mL) and ammonium chloride (12.36 mg/mL). Cohort 3: Citramel High Dose (if administered) - an aqueous solution of sodium citrate (64.72 mg/mL), citric acid (0.184 mg/mL) and ammonium chloride (16.48 mg/mL). Administered by aerosol twice daily (morning and night) for 28 days. Compliance will be assessed by checking the vials returned by study participants.
Sponsors
Breathe Easy Limited
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers aged 18-60 years who provide written informed consent; BMI 18-32 kg/m2; FEV1 between 80-120% of normal range; sexually active females must use effective contraception.
Exclusion criteria
Clinically significant co-existing disease; smoker; any medications (except oral contraceptives); ECG or blood pressure abnormalities; positive results on drugs of abuse or alcohol screen; greater than 15% improvement in FEV1 15 minutes post dose of bronchodilator at screening; known exposure to ammonium chloride in the workplace; hospital admission in previous 30 days;
Outcome results
None listed