None listed
Conditions
Interventions
Intervention1: SMRX11: Proposed plan doses are 1, 3, 10 and 20mg
Frequency: Single dose
Route of administration: Intravenous Injection
Duration of therapy: Bolus dose over an approximate 1-minute peri
Sponsors
Dr Yatindra Prashar
Eligibility
Inclusion criteria
Inclusion criteria: - Male subjects aged between 18 and 65 years (including both) with BMI between 20 to 25 kg/m2 (including both). - Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range. - Subjects having clinically acceptable 12-lead electrocardiogram (ECG). - Subjects having clinically acceptable X-Ray chest (PA view). - Have a negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine). - Have negative alcohol breath test. - Subjects willing to adhere to the protocol requirements and to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Has a history of hypersensitivity or allergies to similar class of drug as the study drug. 2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 3. Use of any prescribed medication (including aspirin and aspirin-containing products) during last two weeks or OTC medicinal products (including herbal preparations) during the last one week prior to initiation of study. 4. Use previous use of streptokinase, blood thinners (e.g., warfarin/Coumadin), thrombolytic agents, Statins, Clopidogrel and/or antihypertensive drugs. 5. Subjects with severe and uncontrolled hypertension (blood pressure above 160/100 mmHg); or documented hypotension. 6. History of spontaneous subcutaneous edemas. 7. History or presence of significant asthma, urticaria or other allergic reactions. 8. History or presence of significant gastric and/or duodenal ulceration. 9. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour. 10. History or presence of significant alcoholism or drug abuse in the past one year. 11. History or presence of smoking or use of other tobacco, pan, gutkha products since last 06 months. 12. History or presence of cancer. 13. Difficulty with donating blood. 14. Major illness during 3 months before screening. 15. Participation in a drug research study within past 3 months. 16. Donation of blood in the past 3 months before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characerize the Pharmacokinetics of SMRX11 in healthy male subjects following a singel intravenous bolus administration To monitor the safety & tolerability on cloatting times and coagulation parametersTimepoint: Total 12 samples(4 ml each)Pre-dose(within 15 min prior to dosing) & Post-dose at 1min, 3min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 8hr, 12hr and 24hr following drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety & tolerability on cloatting times and coagulation parametersTimepoint: Predose - 24 & 12 hr Postdose - 0, 30min, 1,2,4,12,24,48,72hrs | — |
Countries
India
Contacts
Public ContactDr E Venu Madhav
Veeda Clinical Research Pvt Ltd
Outcome results
None listed