A Phase I study of orally inhaled PB01 in healthy male participants following single and repeat administration.

Exclusion Criteria22

• Participants will not be eligible to participate in the study if they meet any of the following criteria:
• Clinically significant disease including airway inflammation, haemoptysis or other respiratory disease (except for completely-resolved childhood asthma and symptom free for greater than 5 years).
• Participants who have a positive urine cotinine test at Screening or Day -1.
• Smokers (i.e. cigarette or tobacco use at any time within the last 18 months).
• Use of caffeine-containing foods/beverages/dietary supplements, decaffeinated beverages or alcohol within 48 hours prior to all visits and/or unable to refrain from their use during the study.
• Use of prescription or non-prescription (over-the-counter) or complementary medicines, within 14 days prior to Day -1, except occasional use of paracetamol (up to 2g per day).
• Respiratory tract infection within the previous four weeks or any infection within 7 days prior to Day -1.
• Any clinically significant abnormalities on clinical chemistry, haematology, urinalysis, physical examination, medical history, 12-lead electrocardiogram (ECG), or vital signs as judged by the investigator or sponsor (at Screening and/or Day -1).
• Clinically significant abnormality of renal function, defined as Cockcroft Gault creatinine clearance less than 70 ml/min.
• Clinically significant abnormality of hepatic function defined as AST or ALT greater than 1.5 times the upper limit of normal.
• History or evidence of, or positive test for HIV, hepatitis B or hepatitis C.
• Positive urine drug screen or alcohol test during Screening or on-study, or history of drug or alcohol abuse and/or dependence within the past year prior to Day -1.
• Participation in another clinical trial or administration of any investigational agent within 8 weeks or 5 half-lives (whichever is longer) prior to Day -1.
• History of clinically significant allergic disease requiring medical treatment with medications as judged by the investigator or sponsor.
• 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 Day -1 or anticipated surgery in the study period.
• Blood or plasma donation of more than 500 mL during the 3 months prior to Day -1.
• 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 or sponsor would jeopardize the safety of the participant or the validity of the study results.
• Unable to refrain from strenuous activity for 48 hours prior to all visits and for the duration of the study.
• 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.