None listed
Conditions
Brief summary
This research project is testing the safety, tolerability and pharmacokinetics (looking at the amount of drug in your blood to evaluate the way the body processes the drug), pharmacodynamics (the response of your body to the drug) and immunogenicity (your immune response to the drug) of a new drug called M012 when it is given as a single dose. M012 is an injection into the skin of your abdomen to be administered by a trained professional.
Interventions
M012 (and matching placebo) will be administered at 7 dose levels. Single doses 0.2mg, 0.6mg, 2mg, up to 5mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses), up to 10mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses) , up to 20mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses) and up to 40mg (exact dose to be decided based on pharmacokinetic information obtained
M012 (and matching placebo) will be administered at 7 dose levels. Single doses 0.2mg, 0.6mg, 2mg, up to 5mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses), up to 10mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses) , up to 20mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses) and up to 40mg (exact dose to be decided based on pharmacokinetic information obtained from previous doses), will be administered subcutaneously. All doses will be administered on-site by study staff.
Sponsors
Merganser Biotech Australia Pty Ltd.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Be a healthy male volunteer age 18-60. 2. Have a body mass index (BMI) between 18.5 and 30 kg/m2 (inclusive). 3. Have laboratory values within the reference range unless deemed not clinically significant by the Investigator. 4. Be surgically sterile, using barrier method of contraception or abstain from sexual intercourse from inpatient admission to one month after dosing. 5. Agree to adhere to the protocol-defined schedule of assessments and procedures. 6. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
Exclusion criteria
1. Have iron deficiency, iron overload, liver disease, renal disease, chronic inflammatory disease, haemochromatosis, beta thalassemia, glucose 6 phosphate dehydrogenase deficiency or hemolytic anaemia. 2. Be a current smoker. 3. Have alcohol intake outside normal limits (> an average of 3 standard drinks per day). 4. Have received a blood transfusion within the last 3 months. 5. Have positive test result for human immunodeficiency virus (HIV). 6. Have positive test result for hepatitis B surface antigen, or hepatitis C antibody. 7. Have donated blood within 4 weeks of screening. 8. Have had recent (within 4 weeks of screening) significant (greater than or equal to 1 unit) blood loss for any reason. 9. Have any evidence of abnormal iron metabolism. During screening, the following indicators must all be within normal limits: Hb, RBC, reticulocyte count, RDW, haematocrit, TSAT, serum ferritin, serum iron and TIBC. 10. Have participated in an investigational drug trial within 30 days prior to first dose of study drug on Day 1. 11. Have a known hypersensitivity to any ingredient in the study formulation. 12. Have, as determined by the Investigator and/or medical monitor, any clinically relevant medical or surgical condition that could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject.
Outcome results
None listed