A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Tolerability of KDF-07002 in Healthy, Adult Volunteers
Nucleus Network, Ltd.
54 participants
Dec 5, 2008
Interventional
Conditions
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
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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 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)
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ACTRN12609000086268