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

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

Plain Language Summary

Simplified for easier understanding

This is an early-stage (Phase 1) safety study testing a new investigational drug called KDF-07002 in healthy adult male volunteers. The purpose is to find out how safe and well-tolerated the drug is when given as a single intravenous (into a vein) dose, and to understand how the body processes it. Different groups of participants will each receive a progressively higher dose. Safety will be monitored closely for 7 days after the dose. You may be eligible if: - You are a male between 18 and 60 years old - You are in good general health with no significant medical conditions - You have easy-to-access veins for blood draws and injections - You agree to use reliable contraception if sexually active during the study and for 30 days after You may NOT be eligible if: - You have a known sensitivity to imaging contrast agents - You use illicit drugs or are alcohol-dependent - You have participated in another drug study in the past 30 days - You have donated blood in the past 30 days or had major surgery or injury in the past 45 days - You have epilepsy, seizures, anaemia, asthma, COPD, liver or kidney disease, or a bleeding disorder - You have had your spleen removed or have a history of pancreatitis - You take warfarin (a blood thinner) - You have an allergy to eggs Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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