None listed
Conditions
Brief summary
Patients with some diseases (e.g some cancers) or donors) may have stem cell mobilization treatments to increase numbers of stem cells released into the blood from bone marrow. These can then be harvested from the blood for the patient to use for replenishment after chemotherapy. Preliminary data in mice and humans support investigating ATL1102 as an agent for mobilising stem cells, in combination with G-CSF. The trial participation period will be approximately six weeks, which includes screening, treatment and post-dose study follow-up. There will be a total of five clinical trial visits per subject.
Interventions
Group A: comparator only
Group B: Investigational product only
Group C: Comparator and investigational product (administered at same time)
Investigational product: 150mg/mL ATL1102 for subcutaneous administration at a dose of 400 mg daily, to be administered on days 1, 3 and 5 to Groups B and C.
Sponsors
Antisense Therapeutics
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
- 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.
Exclusion criteria
- 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
Outcome results
None listed