A single dose, randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics and pharmacodynamics of M012 administered by subcutaneous injection to healthy male volunteers

Phase 2

Recruiting

• Conditions: Beta Thalassemia; Blood - Haematological diseases

• Registration Number: ACTRN12616000093482
• Lead Sponsor: Merganser Biotech Australia Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 56

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified