A Randomised, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of EMP-012 for Injection Administered Subcutaneously to Healthy Volunteers
- Conditions
- Chronic Lung DiseaseRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12624000650594
- Lead Sponsor
- Empirico Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
1.Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
2.Adult males and females, 18 to 65 years of age (inclusive) at screening.
3.Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 32.0 kg/m2, with a body weight less than or equal to 100 kg at screening.
4.Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant (CS) abnormalities including the following:
a.Physical examination without any CS findings.
b.Systolic blood pressure (BP) in the range of 90 to 140 mmHg and diastolic BP in the range of 60 to 90 mmHg after resting for 5 minutes in a supine or semi-supine position.
c.Pulse rate in the range of 50 to 100 bpm after 5 minutes resting in a supine or semi-supine position.
d.Body temperature (tympanic or infrared), between 35.5°C and 37.7°C.
e.Electrocardiogram without clinically significant abnormalities including QT interval corrected for Fredericia (QTcF) <450 msec for male participants and <470 msec for female participants.
f.No CS findings in clinical chemistry, haematology, coagulation, and urinalysis tests.
5.Female volunteers:
a.Must be of non-child-bearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status [>40 U/L], per local laboratory guidelines), or
b.If of child-bearing potential, must:
i.Have a negative pregnancy test at the screening visit and on admission to the study site on Day-1.
ii.Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 6 months after the last dose of study drug.
iii.Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception from one month prior to screening until at least 6 months after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.
6.Male volunteers, must:
a.Agree not to donate sperm from signing the consent form until at least 6 months after the last dose of study drug.
b.If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from signing the consent form until at least 6 months after the last dose of study drug.
c.If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until at least 6 months after the last dose of study drug.
7.Have suitable venous access for blood sampling.
8.Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
1.Known hypersensitivity to the study drug or any of the study drug ingredients.
2.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.
3.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.
4.History of surgery or hospitalization within 3 months prior to screening, or surgery planned during the study.
5.Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma).
6.Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
7.History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
8.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.
9.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.
10.Haemoglobin A1c (HbA1c) >7.0% at Screening.
11.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.
12.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).
13.Suspicion of, or known Gilbert’s syndrome.
14.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.
15.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.
16.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]).
17.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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method