Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000086268
Ethics application status
Approved
Date submitted
4/12/2008
Date registered
9/02/2009
Date last updated
9/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Tolerability of KDF-07002 in Healthy, Adult Volunteers
Scientific title
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Tolerability of KDF-07002 in Healthy, Adult Volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 4068 0
Condition category
Condition code
Other 4275 4275 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3788 0
Treatment: Drugs
Comparator / control treatment
Single intravenous infusion of saline for injection based on the same volume as the active drug at the respective dose level (i.e. 0.013, 0.026, 0.053,
0.105, 0.158, 0.237, 0.356, 0.533, 0.800 mL/kg of bodyweight).
Control group
Placebo

Outcomes
Primary outcome [1] 5160 0
Safety and maximum tolerated dose of KDF 07002. Safety assessments of participants will be performed by the Pricipal Investigators and Medical Monitors of the study based on vital signs, ECG, and clinical chemistry values.
Timepoint [1] 5160 0
Participants will be monitored in the clinical unit for 48 hours then released. Particiapnts are requyired to return to the clinic on day 7 for follow-up assessment of ECG, vital signs, including blood pressure, heart rate, and respiratory rate measurements; a blood sample will be taken for clinical chemistry, hepatic profile, renal profile, hematology, and coagulation measures
Secondary outcome [1] 8684 0
Whole blood samples will be taken for analysis of KDF-07002 to determine the Pharmacokinetic profile of KDF-07002. Trained scientists will use special software to analyze the resutls to determine how quickly the KDF-07002 exits the bloodstream.
Timepoint [1] 8684 0
at baseline, 5 minutes, 0.25, 0.5, 1, 2, 4, 8, 12, 24, and 48 hours after infusion

Eligibility
Key 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
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Upon confirmation of all entry criteria, subjects will be assigned a randomisation number. At the site, the investigator will use the next available subject number and retrieve the envelope for that subject number. The pharmacist at the Study site will be able to determine, from the assigned subject number and the randomisation schedule provided, the correct Clinical Trial Material (CTM) vial to be used (active or placebo).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The independent statistician will generate the randomisation schedule with the statistical software SAS.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/12/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4247 0
Commercial sector/Industry
Name [1] 4247 0
Kereos, Inc.
Country [1] 4247 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nucleus Network, Ltd.
Address
5th Floor, Burnet Tower, The Alfred Medical Research and Education Precinct (AMREP)
89 Commercial Road
Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 3820 0
None
Name [1] 3820 0
Address [1] 3820 0
Country [1] 3820 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6298 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 6298 0
Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 6298 0
Australia
Date submitted for ethics approval [1] 6298 0
30/04/2008
Approval date [1] 6298 0
20/11/2008
Ethics approval number [1] 6298 0
121/08

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29197 0
Address 29197 0
Country 29197 0
Phone 29197 0
Fax 29197 0
Email 29197 0
Contact person for public queries
Name 12354 0
Associate Professor Peter Hodsman
Address 12354 0
5th Floor, Burnet Tower, The Alfred Medical Research and Education Precinct (AMREP)
89 Commercial Road
Melbourne, Victoria 3004
Country 12354 0
Australia
Phone 12354 0
+61-(0)3-9076 8960
Fax 12354 0
+61-(0)3-9076 8940
Email 12354 0
p.hodsman@nucleusnetwork.com.au
Contact person for scientific queries
Name 3282 0
Associate Professor Peter Hodsman
Address 3282 0
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne, Victoria 3004
Country 3282 0
Australia
Phone 3282 0
+61-(0)3-9076 8960
Fax 3282 0
+61-(0)3-9076 8940
Email 3282 0
p.hodsman@nucleusnetwork.com.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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