A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV1729 in Healthy Subjects for up to 28 Days and Subjects With Stable Asthma for 14 Days
Overview
- Phase
- Phase 1
- Intervention
- RV1729 14 day repeat dose
- Conditions
- Asthma
- Sponsor
- Respivert Ltd
- Enrollment
- 49
- Primary Endpoint
- Vital sign assessment (blood pressure and heart rate, measured together)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
RV1729 is a new medicine being developed for the potential treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD).
The objective of this study is to investigate the safety, tolerability and pharmacokinetics of single doses of RV1729 and repeat doses of RV1729 for up to 28 days.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be a man or woman between 18 to 60 years of age, inclusive, at the time of signing the informed consent.
- •Cohorts 1, 2 \& 3 women of childbearing potential must have a documented menstrual period prior to the first dose and be willing to use 2 forms of appropriate methods of contraception from screening until 4 months after the final dose of RV1729, OR
- •Women of non-childbearing potential must be spontaneously amenorrhoeic for at least 1 year or have been permanently sterilised, OR
- •If a man, must be willing and able to use one of the contraception methods listed in the protocol and agree not to donate sperm from screening until 4 months after the final dose of RV1729
- •Women must agree not to donate eggs (ova, oocytes) from screening until at least 6 months after the final dose of RV1729
- •Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •Body mass index between 19 and 30 kg/m2 and body weight not less than 50 kg.
- •Vital sign assessments within normal ranges
- •Have a 12-lead ECG recording consistent with normal cardiac function
- •Capable of complying with all study restrictions and procedures including ability to use the study inhaler correctly
Exclusion Criteria
- •Upper or lower respiratory tract infection within 4 weeks before screening
- •Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening or Day -1
- •Has a history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease.
- •History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years.
- •Positive test for alcohol or drugs of abuse, including cannabinoids, alcohol, opiates, cocaine, amphetamines, benzodiazepines or barbiturates at screening or on Day -1
- •History of clinically significant allergies that, in the opinion of the Investigator or Medical Monitor, would contraindicate their participation.
- •Subjects known to suffer from hayfever, or other allergy, that may require antihistamine therapy during the course of the study.
- •Known allergy to the study drug or any of the excipients of the formulation or has previously been exposed to RV
- •Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months or intention to donate blood or blood products during the study.
- •Received an experimental drug or used an experimental medical device within 3 months or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled.
Arms & Interventions
14 day repeat dose (asthma patients)
Intervention: RV1729 14 day repeat dose
14 day repeat dose (asthma patients)
Intervention: RV1729 matching placebo 14 day repeat dose
28 day repeat dose (healthy volunteers)
Intervention: RV1729 28 day repeat dose
Single dose (healthy volunteers)
Intervention: RV1729 single dose
Single dose (healthy volunteers)
Intervention: RV1729 matching placebo single dose
14 day repeat dose (healthy volunteers)
Intervention: RV1729 14 day repeat dose
14 day repeat dose (healthy volunteers)
Intervention: RV1729 matching placebo 14 day repeat dose
28 day repeat dose (healthy volunteers)
Intervention: RV1729 matching placebo 28 day repeat dose
Outcomes
Primary Outcomes
Vital sign assessment (blood pressure and heart rate, measured together)
Time Frame: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Change from pre-dose values
Incidence of treatment emergent adverse events
Time Frame: Cohort 1, 56 days: Cohorts 2 & 3, 70 days: Cohort 4, 84 days
Assessment of the number of adverse events reported by subjects following dosing
ECG assessment (12-lead ECG)
Time Frame: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Change from pre-dose values
Clinical laboratory assessments (blood and urine samples, collected together)
Time Frame: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Change from pre-dose values
Spirometry assessment (FEV1 & FVC)
Time Frame: Cohort 1, 29 days: Cohorts 2 & 3, 42 days: Cohort 4, 56 days
Change from pre-dose values
Secondary Outcomes
- Plasma RV1729 levels(Cohort 1: Day 1, 7 samples, Day 2-29, 5 samples; Cohorts 2 & 3: Days 1, 7 & 14, 8 samples, Days 2 & 8-13, 1 sample per day, Days 15-42, 6 samples; Cohort 4: Days 1, 14 & 28, 8 samples, Days 2, 7, 15, 21, 26 & 27, 1 sample per day, Days 29-70, 7 samples;)