Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Respivert Ltd
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Be a man or woman between 18 to 50 years of age, inclusive, at the time of signing the informed consent
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
If a woman of childbearing potential, must have a documented menstrual period prior to the first dose and be willing and able to use two forms of contraception from screening to 90 days after the final dose of RV1729, OR
If a woman of non-childbearing potential must be amenorrhoeic for greater than 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, the first dose until 90 days after they receive the final dose of RV1729.
Body mass index between 19 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
Vital sign assessments within normal ranges: blood pressure between 90 and 140 mmHg systolic, inclusive, and between 40 and 90 mmHg diastolic; heart rate 40 - 100 bpm
Have a 12-lead ECG consistent with normal cardiac conduction and function
Capable of complying with all study restrictions and procedures including ability to use the study Dry Powder Inhaler correctly
Parts A \& B (healthy volunteers only)
Healthy as determined by a physician, based on a full medical evaluation including medical history, physical examination, laboratory tests.
Prebronchodilator spirometry readings (FEV1 and FVC) to be ≥ 80% predicted value and FEV1/FVC ratio \> 0.7 at screening
Are not taking prescription medications for 14 days prior to screening and agree not to use prescription medications throughout the duration of the study.
Not taking over the counter medications for 14 days prior to Screening visit to the final follow up visit
Part C (asthma patients only)
Documented history of asthma, for at least 6 months prior and currently being treated with as needed short-acting beta -agonist therapy and daily inhaled corticosteroids
Have a diagnosis of asthma. This may be confirmed with bronchodilator reversibility or a challenge test.
Have a pre-bronchodilator forced expiratory volume in the first second (FEV1) ≥ 65% of predicted normal value
Treated with a stable low or medium dose of inhaled corticosteroid for at least 4 weeks prior to screening
Have stable asthma based on physician assessment at screening with no asthma exacerbation requiring augmentation of therapy in the 12 weeks prior to screening and no hospitalisation for asthma in the 5 years prior to screening
Not have a clinical abnormality or laboratory parameters outside the reference range for the population being studied
Not taking over the counter (OTC) medications and herbal medication for 14 days prior to screening visit and up to the final follow up visit
You may not be if
Upper or lower respiratory tract infection within 4 weeks of the screening visit
Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening
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 at screening or prior to dosing
History of clinically significant allergies that would contraindicate participation
Known allergy to the study drug or any of the excipients of the formulation
Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before 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 before the first dose of the study drug is scheduled
If a woman, has a positive serum pregnancy test at screening or on admission, is pregnant, breast-feeding or planning to become pregnant during the study
Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus (HBV) infection, or hepatitis C antibodies
History of smoking or use of nicotine-containing substances within the previous 6 months, or a positive carbon monoxide test at screening
Preplanned surgery or procedures that would interfere with the conduct of the study
Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities
History of regular alcohol consumption within 6 months of the study
The subject is unable or unwilling to comply fully with the study protocol
Subject is mentally or legally incapacitated
Unable or unwilling to undergo multiple venepuncture procedures or the subject has poor access to veins suitable for cannulation
Any other reason that the Investigator considers makes the subject unsuitable to participate
Part C (asthma patients only)
Administration of oral, injectable or dermal steroids within 3 months or intranasal steroids within 1 week of the screening visit.
Has ever had an episode of life-threatening asthma
Any acute or chronic illness or clinically relevant abnormality other than asthma
Use of Cysteine within 24 hours of screening and throughout the study period
Has severe asthma based on Investigator assessment
Clareo Health | A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of RV1729
