A Phase I, Randomised, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Doses of ATL1102 Alone and in Combination with G-CSF in Healthy Volunteers
- Conditions
- Stem cell mobilisationBlood - Haematological diseases
- Registration Number
- ACTRN12614000200684
- Lead Sponsor
- Antisense Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 10
Provide written informed consent
- Male subjects 18 – 50 years of age inclusive
- Body Mass Index (BMI) >=19 and <= 32 kg/m2
- Healthy as determined by medical and drug history, physical examination, vital signs, clinical laboratory testings including urinalysis, and ECG.
- Allergy and/or hypersensitivity to any of the ingredients of ATL1102 or to E. coli derived proteins, filgrastim, or any component of Neupogen (registered trademark).
- History or presence of clinically significant haematological abnormalities
- Current or prior history within the last 5 years of cancer (except for treated BCC SCC of the skin with no evidence of recurrence)
- History or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular, or infectious disease, or any acute infectious disease.
- Received an investigational drug within 30 days or 5 half-lives prior to the first dose of study drug, whichever is the longer period.
- Blood donation or loss of >500ml within 3 months prior to the first dose of study drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of subcutaneous doses of ATL1102 alone, and in combination with G-CSF in healthy volunteers[ - Signs, symptoms or markers of end organ or systemic toxicity during the 14 day study period<br> - Physical examination changes during the 14 day study period<br> - Vital signs (temperature, respiration rate, pulse rate, blood pressure) pre and post dose and in follow up.<br> - Adverse event questioning and recording throughout the 14 day study<br> - 12-lead ECG (including heart rate, PR, QRS and QTc interval) pre and post dose and in follow up.<br> - Clinical laboratory assessments including haematology, biochemistry, coagulation studies and urinalysis pre and post dose and in follow up<br> - Complement Bb pre and post dose and in follow up.];To assess the plasma pharmacodynamics of ATL1102 alone, and in combination with G-CSF in healthy volunteers[Cmax, Tmax, and AUC after single (Day 1) and multiple doses of ATL1102 (Days 3, 6, 7, 8 and 14)]
- Secondary Outcome Measures
Name Time Method one[NA]