A Phase 1, Randomised, Double-blind, Placebo-controlled, First in Human Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of MVD1 in Normal Weight or Overweight Healthy Adult Volunteers and Multiple Doses of MVD1 in Overweight or Obese Healthy Adult Volunteers
- Conditions
- ObesityMetabolic DisordersDiet and Nutrition - ObesityMetabolic and Endocrine - Metabolic disorders
- Registration Number
- ACTRN12622001519741
- Lead Sponsor
- Eolo Pharma Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 41
Inclusion Criteria Cohorts S1 to S3:
1.Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2.Male or female, 18-60 years of age inclusive at the time of screening.
3.Body mass index (BMI) = 20 and < 30 kg/m2 at the time of screening.
4.Female participants:
a. Must be of non-childbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy or bilateral tube ligation/occlusion at least 6 weeks before the Screening visit) or postmenopausal where menopause is defined as 12 months of amenorrhea without an alternative medical cause (females must have a documented serum follicle stimulating hormone level consistent with postmenopausal status, per local laboratory guidelines) OR
b.If of childbearing potential (defined as any female who has experienced menarche and who has not undergone surgical sterilisation and is not postmenopausal), must agree not to attempt to become pregnant, must not donate ova and must agree to use an acceptable form of contraception from signing the consent form until at least 30 days after the last dose of study drug.
5.Male participants:
a.Must be biologically or surgically sterile (i.e, have had a vasectomy at least 3 months prior to screening) OR
b.If not biologically or surgically sterile, must agree not to donate sperm and must agree to use an acceptable contraceptive method in addition to having the female partner use an acceptable contraceptive method from signing the consent form until at least 90 days after the last dose of study drug.
6.Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.
Inclusion Criteria Cohorts M1 to M3:
1.Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2.Male or female, 25-60 years of age inclusive at the time of screening.
3.In good health as determined by the outcome of medical history, physical examination, and clinical judgement by the Investigator. Chronic stable non-inflammatory conditions such as abnormal fasting glycemia, hypertension, hyperlipidemia, osteoarthritis, gout, Chronic Pain Disorders, Thyroid Disease, controlled psychiatric conditions such as anxiety or depression, are permitted, as determined by the Investigator.
4.Body mass index (BMI) between 28 and 35 kg/m2 inclusive at the time of screening.
5.Female participants:
a.Must be of non-childbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy or bilateral tube ligation/occlusion at least 6 weeks before the Screening visit) or postmenopausal where menopause is defined as 12 months of amenorrhea without an alternative medical cause (females must have a documented serum follicle stimulating hormone level consistent with postmenopausal status, per local laboratory guidelines) OR
b.If of childbearing potential (defined as any female who has experienced menarche and who has not undergone surgical sterilisation and is not postmenopausal), must agree not to attempt to become pregnant, must not donate ova and must agree to use an acceptable form of contraception from signing the consent form until at least 3
Exclusion Criteria Cohorts S1 to S3:
1.History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant
2.Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications
3.Any history of malignant disease in the last 10 years (excludes surgically resected skin and in situ cervical squamous cell or basal cell carcinoma)
4.Screening 12-lead ECG outside the normal range for the triplicate mean (QT interval corrected using the Fridericia method (QTcF) males > 450 msec; females > 470 msec) or with abnormalities, which are hazardous to the participant according to the opinion of the Investigator
5.Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia
6.Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months prior to the first study drug administration
7.History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrhythmia
8.Change in body weight of = 5 % within 6 months prior to screening visit
9.Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total or unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT).
10.Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit
11.Presence or having sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
12.Estimated glomerular filtration rate (eGFR) < 60 mL/min /1.73 m2 or serum creatinine more than 1.5-fold above the ULN
13.History of substance abuse or alcohol abuse (defined as more than 10 standard drinks per week or regularly consuming more than 4 standard 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], 30 mL spirit [40% Alc./Vol]) within 12 weeks prior to the screening visit
14.Positive urine cotinine, drugs of abuse or alcohol breath test results at the screening visit or at check-in (Day -1).
15.Use of any prescription or over-the-counter medication (including herbal products, diet aids, hormone supplements, topical ointments, vitamins and dietary supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, with the exception of hormonal contraceptives, medications used to manage AEs including the occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days).
16.Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the o
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method