None listed
Conditions
Brief summary
This is a Phase 1a, single-center, randomized, double blind, placebo controlled, dose escalating study to evaluate the safety, tolerability, and Pharmacokinetic (PK) profiles of a single, intravenous dose of KDF-07002 in healthy adults. Up to 54 subjects will be sequentially enrolled into one of nine cohorts. Each cohort will be randomised to receive KDF 07002 or placebo at a 2:1 ratio. All eligible subjects will be assigned an enrollment number in sequential order beginning with 01. After completion of screening, eligible subjects will be randomized to receive KDF-07002 or placebo at a ratio of 2:1. Each cohort will receive KDF-07002 in the following ascending dose order: 0.013, 0.026, 0.053, 0.105, 0.158, 0.237, 0.356, 0.533, 0.800 mL/kg of bodyweight. Safety and tolerability will be assessed immediately after dosing until Day 7.
Interventions
KDF-07002 will be adminstered in the morning on day 1 of the study as a single intravenous infusion. The doses in the study will be 0.013, 0.026, 0.053,
0.105, 0.158, 0.237, 0.356, 0.533, and 0.800 mL/kg of bodyweight. Duration of infusion will be based on dose but should not exceed 1 hour. Particiapnats will be observed for 48 hours in clinic, released with a followup visit ocurring on day 7. Escalation of dose will proceed based on results of vital signs and clinical chemistry analyses.
Sponsors
Nucleus Network, Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Be a male between the ages of 18 and 60 years, inclusive. 2. Be healthy and have an acceptable medical history (defined as individuals who in the view of the investigator are free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, infective, or psychiatric diseases and confirmed by medical history, physical examination, and laboratory tests). 3. Have readily accessible peripheral venous access sites for administration of clinical trial material and blood sampling. 4. Subjects who are sexually active must also agree to a reliable form of contraception during the study and for 30 days following administration of the study drug. 5. Have the ability to understand the requirements of the study, be willing to provide written informed consent as evidenced by signature on an informed consent document approved by the institution’s Human Research Ethics Committee (HREC), and agree to abide by the study restrictions
Exclusion criteria
1. Have a known sensitivity to any imaging contrast agents 2. Be an intravenous drug user, user of any illicit drugs, or dependent on alcohol 3. Have participated in an investigational drug or device study within the past 30 days 4. Have donated blood or blood products within the past 30 days prior to pretreatment baseline period. 5. Have had surgery or suffered injury involving significant blood loss within the past 45 days prior to pretreatment baseline period. 6. Have any clinically significant abnormal laboratory test based on clinical chemistry, hepatic profile, renal profile, hematology, or coagulation measures 7. Have epilepsy or a history of grand mal seizure 8. Have a red blood cell disorder such as hemoglobinopathies or anemia 9. Have asthma, Chronic Obstructive Pulmonary Disease, Restrictive Pulmonary Disease or any other allergic respiratory diseases 10. Have hepatic disease (liver function tests greater than 1.5 times the upper limit of normal) 11. Have renal impairment with serum creatinine > 105 mmol/L and/or Glomerular Filtration Rate (GFR) <60 mL/min. 12. Have splenic disorders such as hepatosplenomegally, splenomegally or splenectomy 13. Have a history of pancreatitis 14. Have thrombocytopenia (<150,000 platelets/mm3) 15. Have a blood-clotting disease including hemophilia or von Willebrand disease 16. Be currently taking warfarin (Coumadin®) 17. Have a known allergy to eggs
Outcome results
None listed