A Phase I study of inhaled PB01 in healthy male volunteers to assess the anti-inflammatory effects of PB01 on lung inflammation.

Exclusion Criteria21

• Participants will not be eligible to participate in the study if they meet any of the following criteria:
• Clinically significant respiratory disease including airway inflammation, haemoptysis or other respiratory disease (except for completely-resolved childhood asthma and symptom free for greater than 5 years).
• Current smokers or ex-smokers who have given up smoking for less than 12 months and/or have a smoking pack history of greater than 5 pack years (1 pack year equals 20 cigarettes per day for 1 year or 5 cigarettes per day for 4 years).
• Participants with any currently active infection, or who have a previous respiratory tract infection that resolved less than 4 weeks prior to screening or to randomisation, or any other previous infection that resolved less than 7 days prior to screening or to randomisation.
• Any clinically significant abnormalities on physical examination, medical history, 12-lead electrocardiogram (ECG), or vital signs as judged by the investigator and in consultation with the sponsor if required.
• Any clinically significant abnormalities on clinical laboratory tests (clinical chemistry, liver function, haematology, coagulation profile and urinalysis) at screening. Note: These screening laboratory samples must be obtained no more than 7 days prior to randomisation.
• Clinically significant abnormality of renal function, defined as Cockcroft Gault creatinine clearance less than 70 ml/min. Note: These screening laboratory samples must be obtained no more than 7 days prior to randomisation.
• Clinically significant abnormality of hepatic function defined as AST or ALT greater than 1.5 times the upper limit of normal. Note: These screening laboratory samples must be obtained no more than 7 days prior to randomisation.
• History or evidence of, or positive test for Hepatitis B, Hepatitis C and HIV.
• Positive urine drug screen, urine cotinine test or alcohol breath test at screening or prior to randomisation, or a history of drug or alcohol abuse and/or dependence within the past year prior to screening.
• Administration of any investigational agent within 8 weeks or 5 half-lives (whichever is longer) prior to screening.
• History of clinically significant allergic disease requiring medical treatment with medications as judged by the investigator and in consultation with the sponsor if required.
• History of hypersensitivity to follistatin or drugs of the same pharmacological class.
• Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion.
• Major surgery within 3 months prior to screening or anticipated surgery in the study period.
• Blood or plasma donation of more than 500 mL during the 3 months prior to screening or randomisation.
• History of or current clinically-significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunological, neurological, ophthalmological, haematological or psychiatric disorder or any other condition, which in the opinion of the investigator and in consultation with the sponsor if required would jeopardize the safety of the participant or the validity of the study results.
• History of significant drug hypersensitivity, milk protein allergy, hypersensitivity to inhalation challenges, or any history of anaphylactic reactions.
• Participants who have undergone an lipopolysaccharide (LPS) challenge within the previous month prior to screening or a history of significant adverse reaction to LPS challenge.
• Unable to use nebuliser.
• An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, sibling, or child, whether biological or legally adopted.