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RecruitingPhase 1ACTRN12609000086268

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Tolerability of KDF-07002 in Healthy, Adult Volunteers

Sponsor

Nucleus Network, Ltd.

Enrollment

54 participants

Start Date

Dec 5, 2008

Study Type

Interventional

Conditions

This trial is to assess safety and tolerability of KDF-07002 in healthy adult males and dose not focus on any particular health condition or problem

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.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 60 Yearss

Inclusion Criteria5

  • Be a male between the ages of 18 and 60 years, inclusive.
  • 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).
  • Have readily accessible peripheral venous access sites for administration of clinical trial material and blood sampling.
  • 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.
  • 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 Criteria21

  • Have a known sensitivity to any imaging contrast agents
  • Be an intravenous drug user, user of any illicit drugs, or dependent on alcohol
  • Have participated in an investigational drug or device study within the past 30 days
  • Have donated blood or blood products within the past 30 days prior to pretreatment baseline
  • period.
  • Have had surgery or suffered injury involving significant blood loss within the past 45 days
  • prior to pretreatment baseline period.
  • Have any clinically significant abnormal laboratory test based on clinical chemistry, hepatic
  • profile, renal profile, hematology, or coagulation measures
  • Have epilepsy or a history of grand mal seizure
  • Have a red blood cell disorder such as hemoglobinopathies or anemia
  • Have asthma, Chronic Obstructive Pulmonary Disease, Restrictive Pulmonary Disease or any
  • other allergic respiratory diseases
  • Have hepatic disease (liver function tests greater than 1.5 times the upper limit of normal)
  • Have renal impairment with serum creatinine > 105 mmol/L and/or Glomerular Filtration Rate (GFR) <60 mL/min.
  • Have splenic disorders such as hepatosplenomegally, splenomegally or splenectomy
  • Have a history of pancreatitis
  • Have thrombocytopenia (<150,000 platelets/mm3)
  • Have a blood-clotting disease including hemophilia or von Willebrand disease
  • Be currently taking warfarin (Coumadin®)
  • Have a known allergy to eggs

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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

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.

Locations(1)

Australia

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ACTRN12609000086268