Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000412336
Ethics application status
Not yet submitted
Date submitted
21/07/2008
Date registered
22/08/2008
Date last updated
22/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Part 3 of a study to evaluate the safety of a single dose of increasing amounts of INO-4885 given via a vein to healthy adult male volunteers
Scientific title
A Phase I, Single-Center, Randomized, Single-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of an Intravenous Infusion of INO-4885 Administered to Healthy Adult Male Volunteers – Part 3
Secondary ID [1] 642 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
No specific health condition being studied - the study is being conducted for safety reasons in healthy male volunteers that do not belong to any target population for the given intervention 3447 0
Condition category
Condition code
Other 3602 3602 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the completed Parts 1 and 2 of this trial, the tolerability and safety of intravenous doses of INO-4885 ranging from 1-600 mcg/kg administered to healthy adult volunteers was established . Based upon these findings and animals toxicology (safety ) studies, 1200 mcg/kg of INO-4885 will be administered intravenously to healthy adult volunteers in this trial (Part 3) at a rate of 15 mL/min.
Intervention code [1] 3177 0
Treatment: Drugs
Comparator / control treatment
The placebo is standard 0.9% normal saline (salt water) to be administered intravenously at 15 mL per minute.
Control group
Placebo

Outcomes
Primary outcome [1] 4501 0
Tolerability and Safety: results of physical examinations, vital signs, clinical laboratory tests, electrocardiogram (ECG) tracings, drug exposure, concomitant medications, withdrawals/termination, renal safety biomarkers, and adverse events (AEs) will be used to assess tolerability and safety. Adverse events such as clinically significant abnormal findings on safety tests reported by the investigators and events reported by enrolled subjects will be recorded, listed, and reviewed.
Timepoint [1] 4501 0
Physical examinations at Screening and Days 0, 1, 2, and 7; vital signs at Screening, Day 0, Day 1 (pre-dose and immediately following conclusion of the study drug infusion, every half hour for 1 hour, every hour for 3 hours, and then every 4 hours for 8 hours), Day 2, Day 3, and Day 7; clinical laboratory tests at Screening and Days 2,3, and 7; electrocardiogram (ECG) tracings at Screening, Days 0, Day 1 (pre-dose and at 0, 20, 60, 120, and 180 min post-dose), and on Days 2, 3, and 7; blood samples for INO-4885 levels and/or kidney safety markers on Day 1 at pre-dose and at 0, 20 and 40 minutes, and at 1, 2, 4, 7, 10, 24, 30, 48, and 54 hours post administration of INO-4885; urine collected for 48 hours on Days 1-3 for levels of INO-4885; and documentation at Screening and on Days 0, 1, 2, 3, and 7 of concomitant medications, withdrawals, terminations, and adverse events (AEs) will be used to assess tolerability and safety.
Secondary outcome [1] 7611 0
Pharmacokinetic profile
Timepoint [1] 7611 0
Blood for INO-4885 levels will be sampled on Day 1 at pre-dose and at 0, 20 and 40 minutes, and at 1, 2, 4, 7, 10, 24, 30, 48, and 54 hours post administration of INO-4885.

Eligibility
Key inclusion criteria
Subject's body weight between 65 and 100 kg and Body Mass Index between 18 and 29, inclusive.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subject received treatment or participated in a study with any investigational product within 30 days prior to study drug administration; subject used tobacco, alcohol, caffeine, vitamins, or herbal medications within 48 hours prior to study drug administration; subject used or required any prescription medications during the 4 weeks prior to study drug administration

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to intervention is randomized controlled trial. Randomisation was accomplished using simple random generation code generated by software purched from Statistical Analysis Software (SAS). Code was written and executed by an outsourced vendor, Medistat, located in Kiryat Atidim, Israel. The vendor also prepared the opaque envelopes and randomisation lists.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
17/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3631 0
Commercial sector/Industry
Name [1] 3631 0
Inotek Pharmaceuticals Corporation
Country [1] 3631 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Inotek Pharmaceuticals Corporation
Address
100 Cummings Center, Suite 419E
Beverly, Massachusetts 01915
Country
United States of America
Secondary sponsor category [1] 3265 0
None
Name [1] 3265 0
Address [1] 3265 0
Country [1] 3265 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5684 0
The Alfred Hospital Human Research and Ethics Committee
Ethics committee address [1] 5684 0
Ethics committee country [1] 5684 0
Australia
Date submitted for ethics approval [1] 5684 0
20/06/2008
Approval date [1] 5684 0
Ethics approval number [1] 5684 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28756 0
Address 28756 0
Country 28756 0
Phone 28756 0
Fax 28756 0
Email 28756 0
Contact person for public queries
Name 11913 0
Chaim Brickman
Address 11913 0
100 Cummings Center, suite 419E
Beverly, Massachusetts 01915
Country 11913 0
United States of America
Phone 11913 0
+1-978-232-9660, ext 8805
Fax 11913 0
Email 11913 0
cbrickman@inotekcorp.com
Contact person for scientific queries
Name 2841 0
Chaim Brickman
Address 2841 0
100 Cummings Center, suite 419E
Beverly, Massachusetts 01915
Country 2841 0
United States of America
Phone 2841 0
+1-978-232-9660, ext 8805
Fax 2841 0
Email 2841 0
cbrickman@inotekcorp.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.