Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05126784
Registration number
NCT05126784
Ethics application status
Date submitted
1/11/2021
Date registered
19/11/2021
Date last updated
29/05/2024
Titles & IDs
Public title
AVT03 With Prolia in Healthy Male Subjects
Query!
Scientific title
A Randomized, Double-blind, Single-dose, Parallel-group Design, 2 Arm Study Comparing the Pharmacokinetic, Pharmacodynamic, Safety, Tolerability, and Immunogenicity Profiles of AVT03 and Prolia® in Healthy Male Subjects
Query!
Secondary ID [1]
0
0
AVT03-GL-P01
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Healthy Male Subjects
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - AVT03
Other interventions - Prolia
Experimental: AVT03 Arm - AVT03 (denosumab) is the proposed biosimilar for Prolia (denosumab). Subjects in this arm will receive a single 60mg dose of AVT03 (denosumab) as a subcutaneous injection.
Active Comparator: Prolia Arm - Prolia(denosumab) is the proposed comparator for AVT03 (denosumab). Subjects in this arm will receive a single 60mg dose of Prolia (denosumab) as a subcutaneous injection.
Other interventions: AVT03
AVT03 (biosimilar to denosumab) will be given as single subcutaneous injection
Other interventions: Prolia
Prolia (denosumab) will be given as single subcutaneous injection
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Area under the serum concentration-time curve (AUC0-last) from day 0 to day 252
Query!
Assessment method [1]
0
0
Venous blood samples will be collected for measurement of Area under serum concentration-time curve (AUC 0-t) AVT03 and Prolia
Query!
Timepoint [1]
0
0
Day 1(week 1) to Day 252 (week 36)
Query!
Primary outcome [2]
0
0
Area under the serum concentration-time curve (AUC0-inf) from day 0 to day 252
Query!
Assessment method [2]
0
0
Venous blood samples will be collected for measurement of CTX-1 serum biomarker for AVT03 and Prolia.
Query!
Timepoint [2]
0
0
Time Frame: Day 1(week 1) to Day 252 (week 36)]
Query!
Primary outcome [3]
0
0
Maximum serum concentration Cmax from day 0 to day 252
Query!
Assessment method [3]
0
0
Venous blood samples will be collected for measurement of maximum serum concentration (Cmax) of AVT03 and Prolia.
Query!
Timepoint [3]
0
0
Day 1(week 1) to Day 252 (week 36)
Query!
Secondary outcome [1]
0
0
PD_AUCE0 for CTX-1 (% inhibition)
Query!
Assessment method [1]
0
0
Venous blood samples will be collected for measurement of serum concentration of AVT03 and Prolia
Query!
Timepoint [1]
0
0
Day 1(week 1) to Day 252 (week 36)
Query!
Secondary outcome [2]
0
0
PK area under the concentration-time curve (AUC0-24) from Day 0 to Day 252
Query!
Assessment method [2]
0
0
Venous blood samples will be collected for measurement of serum concentration of AVT03 and Prolia
Query!
Timepoint [2]
0
0
Day 1(week 1) to Day 162 (week 24)]
Query!
Secondary outcome [3]
0
0
Safety incidence, nature and severity of adverse events
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Screening to Day 252 (week 36)
Query!
Secondary outcome [4]
0
0
Immunogenicity presence and titers of ADAs and presence of nAbs against AVT03 and Prolia
Query!
Assessment method [4]
0
0
Venous blood samples will be collected for measurement of antidrug-antibodies against of AVT03 and Prolia
Query!
Timepoint [4]
0
0
Time Frame: Day 1(week 1) to Day 252 (week 36)
Query!
Eligibility
Key inclusion criteria
- Male subjects who are 28 to 55 years old, inclusive
- Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 17.0 to
32.0 kg/m2 (inclusive)at Screening and Day -1
- Medical history without evidence of a clinically significant disorder, condition, or
disease that, in the opinion of the Investigator, would pose a risk to subject safety
Query!
Minimum age
28
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
- Any evidence of clinically relevant pathology, especially prior diagnosis of bone
disease, or any uncontrolled condition that will affect bone metabolism (such as, but
not limited to osteoporosis, osteogenesis imperfecta, hyperparathyroidism,
hyperthyroidism, hypothyroidism, osteomalacia, rheumatoid arthritis, psoriatic
arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout,
active malignancy, renal disease, Paget's disease of the bone, recent bone fracture
[within 6 months], and malabsorption syndrome)
- Have osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental
procedures (eg, tooth extraction, dental implants, oral surgery) within 6 months prior
to Day 1 or intend to undergo such procedures during the study period, poor oral
hygiene, periodontal, and/or pre existing dental disease
- Have bone fractures within 6 months prior to Day -1.
- Have a history of immunodeficiency
- Those with skin allergies, or are susceptible to autoinflammatory skin disorders, or
prone to the development of allergic skin inflammation
- Abnormal serum calcium: current hypocalcemia or hypercalcemia at Screening. Serum
calcium levels must be within reference ranges.
- Known vitamin D deficiency
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/06/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
16/10/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
209
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Nucleus Network - Herston
Query!
Recruitment postcode(s) [1]
0
0
- Herston
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Christchuch
Query!
Country [2]
0
0
New Zealand
Query!
State/province [2]
0
0
Auckland
Query!
Country [3]
0
0
South Africa
Query!
State/province [3]
0
0
Bloemfontein
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Alvotech Swiss AG
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study has been designed as a randomized, double-blind, single-dose, parallel-group study
in healthy adult male subjects 28 years to 55 years old. The study will assess the PK, PD,
safety, tolerability and immunogenicity of AVT03 compared to Prolia when administered as a
single SC dose.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05126784
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Felicitas Bullo
Query!
Address
0
0
Alvotech
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05126784
Download to PDF