A 3-part study consisting of a randomised, double-blind, placebo-controlled, single ascending dose study in healthy participants, followed by an open-labelled single dose LPS-challenge study in healthy participants and an open-labelled multiple dose study in COPD patients to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EMP-012 for Injection Administered Subcutaneously.

Exclusion Criteria29

• Known hypersensitivity to the study drug or any of the study drug ingredients.
• History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer’s ability to participate in the study.
• History or presence of CS cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal (GI), endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months determined by the PI (or delegate) to be clinically relevant.
• History of surgery or hospitalization within 3 months prior to screening, or surgery planned during the study.
• Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
• Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
• History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
• Presence or having sequelae of GI, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Note: history of cholecystectomy is permitted.
• Liver function test results elevated >1.5-fold above the ULN for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), ALP, AST or ALT. Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the PI (or delegate), if the levels are unaccompanied by clinical signs and are determined to be normal variants.
• Haemoglobin A1c (HbA1c) >7.0% at Screening.
• Haemoglobin <120 g/L for females and <130 g/L for males or haematocrit outside the upper or lower limits of the normal range per reference laboratory at both Screening and Day -1.
• Participants with history or pre-existing renal disease, as defined below:
• a. Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m2 at Screening and Day -1 (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula). Note: one retest of the exclusionary eGFR value is allowed at the discretion of the PI (or delegate).
• b. Urinary albumin-to-creatinine ratio > 10 mg/mmol (100 mg/g).
• Suspicion of, or known Gilbert’s syndrome.
• A history of, or positive test results for human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit.
• Positive drugs of abuse test, cotinine test or alcohol breath test results at the screening visit and/or on admission to the study site on Day 1.
• Regular consumption of more than 10 standard alcoholic drinks/week and/or more than 4 standard alcoholic drinks on any one day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], or 30 mL spirit [40% Alc/Vol]).
• Volunteer smokes more than 5 cigarettes or equivalent nicotine-containing products per week, and/or the volunteer is unwilling to abstain from smoking or the use of nicotine-containing products for 72 hours prior to check-in on Day -1 and throughout the confinement period at the study site.
• Note: 1 average cigar equals approx. 5 average cigarettes; 1 average pipe session equals approx. 5 average cigarettes; 1 average nicotine liquid vape session equals 1 average e-cigarette equals 1 average cigarette.
• Females who are breastfeeding or planning to breastfeed.
• Presence or evidence of recent sunburn, scar tissue, tattoos, or open sores that, in the opinion of the PI (or delegate), would interfere with evaluation of the participant’s response to the study drug.
• Use of any prescription or over-the-counter (OTC) medication within 14 days or 5 half-lives of the medication (whichever is longer) prior to the first dose of study drug, except use of contraceptives, the use of paracetamol (up to 2 g per day) for no more than 3 consecutive days and the use of ibuprofen (up to 1.2 g per day) for no more than 3 consecutive days.
• Use of herbal products, diet aids, vitamins, and/or hormone supplements within 7 days prior to the first dose of study drug.
• Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication within 10 days prior to study drug administration.
• Participant has received a vaccine both within 28 days prior to and 28 days after study drug administration, or plan to receive a live vaccine throughout the duration of the study until completion of the core study follow up period (Day 172), and/or safety extension phase (as applicable).
• Donation of blood or plasma within 30 days prior to study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to study drug administration, or receipt of a blood transfusion within 1 year of study drug administration.
• Participation in another clinical study of an investigational drug or investigational device within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to screening.
• Any other condition or prior therapy that in the opinion of the PI (or delegate) would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.