Chronic Adult Idiopathic Thrombocytopenic Purpura Haematological Disorders Purpura and other haemorrhagic conditions
Conditions
Interventions
sFc?RIIb (SM101) is a recombinant, soluble, non-glycosylated version of the human Fc? receptor Fc?RIIb.
Seven consecutive regular dose groups (0.004, 0.04, 0.4, 1, 2.5, 5 and 10 mg/ kg) will receive
Sponsors
SuppreMol GmbH (Germany)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male, Caucasian subjects aged between 18-40 years (inclusive) 2. Healthy subjects as determined by medical history, physical examination including vital signs, electrocardiography (ECG) and clinical laboratory testing 3. Body weight between 70-90 kg and body mass index (BMI) between 19 and 28 kg/m^2, extremes included 4. ECG recording based on a 12-lead ECG which is normal (PR =100 and =50 and <=90 mmHg), heart rate between 40 and 90 beats per minute (bpm), body temperature <37.5°C 6. Subjects who are able and willing to give written informed consent 7. Normal white blood cell count, C-reactive protein (CRP) and interleukin-6 (IL-6) at screening and on the day before treatment start 8. Subjects must be using two acceptable methods for contraception (e.g. spermicide and condom) during the study and refrain from fathering a child in the 3 months following dosing
Exclusion criteria
Exclusion criteria: 1. In the opinion of the investigator subjects with clinically significant history or presence of cardiovascular, respiratory, renal, hepatic, metabolic, endocrinological, gastrointestinal, hematological, neurological, dermatological, psychiatric diseases, cancer or other major diseases 2. Infection or known inflammatory process 3. Subjects with known autoimmune diseases or immunodeficiency or known family history of autoimmune diseases or immunodeficiency 4. Clinical significant allergic disease 5. Subjects with known serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibodies or with a positive result to the test for HIV 1/2 antibodies 6. Subjects who have received an investigational drug and/or a vaccination within 3 months prior to start of the treatment in study and those who anticipate receipt of a vaccine within 2 months after the last dose of study drug 7. Subjects, who have received prior treatment within 1 year with monoclonal antibodies or other biologic agents 8. The use of any concomitant prescription or non-prescription medication within 14 days prior to the first administration of study medication until follow-up; or treatment with medication that may affect immune function (e.g. immunoglobulins, corticosteroids) within 6 months before dosing 9. Donation of blood (>400 ml) or blood products within the last 3 months prior to admission to the clinical unit or plasmapheresis within 4 weeks prior to study start 10. Definite or suspected personal history of adverse reactions or hypersensitivity to drugs especially to the trial compounds (E. coli-derived proteins, Tween, mannitol) or to compounds with a similar structure 11. Subjects who drink more than 5 cups or glasses of coffee, tea and/or cola per day 12. Subjects with a presence or history of drug and/or alcohol abuse or an average daily intake of more than 20 g alcohol per day 13. Subjects with a positive test for alcohol or drugs at screening and on the day before treatment start 14. Smokers of >5 cigarettes/day or equivalent 15. Subjects who are unlikely to be compliant and attend scheduled clinic visits as required 16. Participation in this study on a previous dose level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessments: 1. Haematology, clinical chemistry, coagulation parameters, urinalysis (screening, day -1, pre-dose and 6, 24, 48 and 72 hours after drug administration and on days 6, 8, 12, and 15, follow-up (FU) at 6 months and FU 1 year) 2. IL-6 and CRP (pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours after start of infusion and on days 6, 8, 12 and day 15, FU 6 months and FU 1 year) 3. Vital signs, 12-lead ECG (screening, day -1, and 8, 10, 12, 16, 24, 36, 48 and 72 hours after drug administration and on day 15, FU 6 months and FU 1 year) 4. Physical examination (screening, day -1, 24 and 48 hours after drug administration and on day 4 before discharge, day 15, FU 6 months and FU 1 year) 5. Local tolerability (day 1 at 0.25, 0.5, 1, 2, 4 and 12 hours after start of infusion, days 2 and 3 and before discharge on day 4) 6. Adverse events (The National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v 3.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic analysis: Pre-dose, 0.25, 0.5, 1, 1.25, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours after start of infusion | — |
Countries
Germany
Outcome results
None listed