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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03390673




Registration number
NCT03390673
Ethics application status
Date submitted
28/12/2017
Date registered
4/01/2018

Titles & IDs
Public title
To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects
Scientific title
A Phase I, Double-blind, Randomised, Single-dose, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects
Secondary ID [1] 0 0
SAMSON-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HD204
Treatment: Drugs - Avastin

Experimental: HD204 - Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion

Active comparator: EU-licensed Avastin - Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion

Active comparator: US-licensed Avastin - Bevacizumab Single-Dose 1mg/kg body weight by 90 minute intravenous infusion


Treatment: Drugs: HD204
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion

Treatment: Drugs: Avastin
Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under Curve (AUC, Pharmacokinetics)
Timepoint [1] 0 0
up to week 12
Secondary outcome [1] 0 0
Immunogenicity
Timepoint [1] 0 0
Days 1 (predose), 15, 22,29, 36, 43, 50, 64, 78 and 95(End of treatment)
Secondary outcome [2] 0 0
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Timepoint [2] 0 0
From Day 1 through study completion (Day 95)

Eligibility
Key inclusion criteria
* Non-smoking healthy male subjects, 18-50 years old inclusive
* Body Mass index is between 19 to 30 kg/m2, inclusive
* NO history of hypersensitivity or allergic reaction to the active ingredient, murine proteins, or excipients, spontaneous or following drug administration.
* For subjects with female partners of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the end of study. Adequate contraception is defined as the usage by the female partner of any form of hormonal contraception or intra-uterine device (which should be established prior to the start of study) plus usage by one of the partners of an additional spermicide-containing barrier method of contraception. The use of a barrier method alone or reliance on abstinence is not considered adequate.
* Subjects must agree not to donate sperm during the study and for 4 months following treatment with the study medication or until scheduled End Of Study (EOS), whichever is longer.
* Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Clinically significant abnormalities in physical examination, laboratory test results or electrocardiogram (ECG)
* Systolic blood pressure > 140 mmHg or < 90 mmHg , or diastolic blood pressure > 90 mmHg or <50 mmHg
* Proteinuria (with a urine dipstick value of 2+ or above)
* Coagulation abnormalities ( i.e., INR > 2x ULN)
* Bleeding diathesis, history of duodenal ulcers, concomitant use of anticoagulants, or any hemorrhage within 6 months prior to study enrollment.
* Surgical procedure within 2 months of screening, or planned surgical procedure within 2 months of EOS
* Positive test result for drugs of abuse or alcohol breathing test.
* Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 or 2.
* Donated or lost > 500ml of blood in the previous 3 months
* Taken an investigational drug within 3 months (or 5 half-lives), whichever is longer.
* Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug or non-prescription drugs (with the exception of paracetamol, which is allowed).
* Previously received bevacizumab or any product considered to be biosimilar to bevacizumab, or any other antibody or protein targeting VEGF or VEGFR.
* Unwillingness or inability to comply with the study protocol for any reason.
* Male subject whose partner is pregnant.
* History or evidence of a clinically significant disorder (including cardiovascular, cerebrovascular, endocrine or psychiatric), or immunocompromised condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
* History of alcohol and/or drug abuse within 12 months of screening.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/03/2019
Sample size
Target
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prestige Biopharma Limited
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Litha Jaison
Address 0 0
Prestige Biopharma Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03390673