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Trial registered on ANZCTR


Registration number
ACTRN12620000013965
Ethics application status
Approved
Date submitted
12/12/2019
Date registered
13/01/2020
Date last updated
27/02/2020
Date data sharing statement initially provided
13/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Compare the Pharmacokinetic Similarity of JHL1266 versus Prolia in Healthy Subjects
Scientific title
A Randomized, Double-Blind, Parallel-Group, Single-Dose, Three-Arm Study to Compare the Pharmacokinetic Similarity of JHL1266 versus Prolia Sourced from EU and US in Healthy Human Subjects
Secondary ID [1] 300063 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 315581 0
Condition category
Condition code
Musculoskeletal 313867 313867 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: JHL1266, a 60 mg single dose subcutaneous injection
Arm 2: Prolia-EU (EU sourced denosumab), a 60 mg single dose subcutaneous injection
Arm 3: Prolia-US (US sourced denosumab), a 60 mg single dose subcutaneous injection
(Regular site monitoring will be performed to ensure fidelity)
Intervention code [1] 316330 0
Treatment: Drugs
Comparator / control treatment
Arm 2: Prolia-EU (EU sourced denosumab), a 60 mg single dose subcutaneous injection
Arm 3: Prolia-US (US sourced denosumab), a 60 mg single dose subcutaneous injection
Control group
Active

Outcomes
Primary outcome [1] 322283 0
To compare the pharmacokinectic parameter of area under the serum drug concentration - time curve from 0 extrapolated to infinity (AUC0-inf) between JHL1266 and Prolia (both EU and US sourced)
Timepoint [1] 322283 0
0 h (pre-dose), 4 h, post- dose (D1), 24h (D2), D3, D5, D9, D11, D15, D22, D29, D43, D57, D71, D85, D99, D113, D127, and D140.
Secondary outcome [1] 377954 0
To compare the change from baseline in serum C-terminal cross-linking telopeptide of type I collagen (CTX1) between JHL1266 and Prolia (both EU and US sourced)
Timepoint [1] 377954 0
0 h (pre-dose), 4 h, post- dose (D1), 24h (D2), D3, D5, D9, D11, D15, D22, D29, D43, D57, D71, D85, D99, D113, D127, and D140.

Eligibility
Key inclusion criteria
1. Willing and able to understand and sign an informed consent inform (ICF);
2. Male age between 25 to 55 years (inclusive); female age between 25 to 45 years (inclusive)
3. Healthy subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests);
4. Body Mass Index (BMI) between 18.0 and 32.0 kg per sq mtr (inclusive) ;
5. Weight between 50 to 100 kg (inclusive);
6. Men and women of childbearing age who have not undergone sterilization surgery must agree to practice effective contraception during the treatment period and within 5 months after the last administration of the study drug;
7. Do not smoke or smoke fewer than 5 cigarettes daily within 3 months prior to screening; do not drink or drink less than 14 units of alcohol within 6 months prior to screening (1 unit of alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine).
8. Able to abstain from caffeine and for the duration of confinement.
Minimum age
25 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Prior diagnosis of bone disease, or any condition that will affect bone metabolism;
2. Osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures, poor oral hygiene, periodontal, and/or pre-existing dental disease;
3. Past history of skin cancer;
4. History of recurrent skin infections or skin conditions;
5. Recent tooth extraction (within 6 months of screening visit);
6. Evidence of hypocalcaemia at screening;
7. Known vitamin D deficiency; or known intolerance to calcium or vitamin D supplements;
8. Any history of clinically serious diseases such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, oncologic, or allergic diseases;
9. Previous exposure to any monoclonal antibody or current use of any biologics for a medical condition or in the context of another clinical trial in the 6 months or 5 half-lives (whichever is longer) prior to screening;
10. History of allergic or anaphylactic reactions including those occurred during any clinical study or those caused by any drug or any of its excipients;
11. Use of prescription or non-prescription drugs and dietary supplements, within 5 half-lives of the drug or supplement, or within 2 weeks prior to taking study drug (whichever is longer), and for the duration of the study until the final follow-up visit. Herbal supplements must be discontinued 14 days prior to the administration of study drug;
12. Prior use of medications used for the treatment or prevention of osteoporosis or medication affecting bone turnover;
13. History of a blood donation within 3 months prior to the administration of study drug;
14. Have participated in any other clinical study within 3 months or 5 half-lives prior to the administration of study drug;
15. Have positive test results for hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies;
16. Women with a positive pregnancy test at screening or Day -1 or planning to become pregnant or lactating;
17. Have a history of drug abuse;
18. Unlikely to comply with the protocol requirements, instructions, and study related restrictions;
19. Subject has the presence of tattoos, sunburn, or other skin disturbances on both the left and right upper arm which may interfere with a medical assessment of the injection site.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2020
Actual
Date of last participant enrolment
Anticipated
1/06/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment outside Australia
Country [1] 22180 0
New Zealand
State/province [1] 22180 0

Funding & Sponsors
Funding source category [1] 304512 0
Commercial sector/Industry
Name [1] 304512 0
JHL Biotech Australia Pty Ltd.
Country [1] 304512 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
JHL Biotech Australia Pty Ltd.
Address
Level 16, Tower 2, Darling Park, 201 Sussex Street Sydney, NSW,2000
Country
Australia
Secondary sponsor category [1] 304798 0
None
Name [1] 304798 0
Address [1] 304798 0
Country [1] 304798 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304943 0
Bellberry Limited Human Research Ethics Committee
Ethics committee address [1] 304943 0
123 Glen Osmond Road Eastwood Adelaide South Australia 5063
Ethics committee country [1] 304943 0
Australia
Date submitted for ethics approval [1] 304943 0
08/01/2020
Approval date [1] 304943 0
24/02/2020
Ethics approval number [1] 304943 0

Summary
Brief summary
This study is a randomized, double-blind, multi-centre, single dose, parallel group, 3-Arm, PK study in healthy subjects. The primary objective is to assess the pharmacokinetic similarity of JHL1266 compared with reference Prolia sourced from the European Union (Prolia-EU) and the United States (Prolia-US) after a single subcutaneous injection in healthy human subjects. The secondary objective is to assess the safety, tolerability, and immunogenicity and PD of JHL1266 as compared to Prolia.
Healthy subjects aged between 25 to 55 (males) or 25 to 45 (females) years old who met the inclusion/exclusion criteria during the screening who met the inclusion/exclusion criteria during the screening period will be enrolled into this study. The enrolled subjects will be randomized into 3 cohorts, JHL1266, Prolia-EU, or Prolia-US. A single 60 mg dose of JHL1266, Prolia-EU or Prolia-US will be administered subcutaneously on Day 1, and subjects will be observed for safety and tolerability and pharmacokinetic and pharmacodynamic blood samples will be collected for 20 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98714 0
Dr Richard Friend
Address 98714 0
Level 5, Clive Berghofer Cancer Research Centre (CBCRC) 300c Herston Rd, Brisbane, 4006 – QLD
Country 98714 0
Australia
Phone 98714 0
+61 03 9076 8960
Fax 98714 0
Email 98714 0
[email protected]
Contact person for public queries
Name 98715 0
Richard Friend
Address 98715 0
Level 5, Clive Berghofer Cancer Research Centre (CBCRC) 300c Herston Rd, Brisbane, 4006 – QLD
Country 98715 0
Australia
Phone 98715 0
+61 03 9076 8960
Fax 98715 0
Email 98715 0
[email protected]
Contact person for scientific queries
Name 98716 0
Rong Chen
Address 98716 0
JHL Biotech Australia Pty Ltd
Level 16, Tower 2, Darling Park, 201 Sussex Street Sydney, NSW,2000
Country 98716 0
Australia
Phone 98716 0
+61 415 247 836
Fax 98716 0
Email 98716 0
[email protected]

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


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.

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