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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
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
Secondary ID [1] 0 0
AVT03-GL-P01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the serum concentration-time curve (AUC0-last) from day 0 to day 252
Timepoint [1] 0 0
Day 1(week 1) to Day 252 (week 36)
Primary outcome [2] 0 0
Area under the serum concentration-time curve (AUC0-inf) from day 0 to day 252
Timepoint [2] 0 0
Time Frame: Day 1(week 1) to Day 252 (week 36)]
Primary outcome [3] 0 0
Maximum serum concentration Cmax from day 0 to day 252
Timepoint [3] 0 0
Day 1(week 1) to Day 252 (week 36)
Secondary outcome [1] 0 0
PD_AUCE0 for CTX-1 (% inhibition)
Timepoint [1] 0 0
Day 1(week 1) to Day 252 (week 36)
Secondary outcome [2] 0 0
PK area under the concentration-time curve (AUC0-24) from Day 0 to Day 252
Timepoint [2] 0 0
Day 1(week 1) to Day 162 (week 24)]
Secondary outcome [3] 0 0
Safety incidence, nature and severity of adverse events
Timepoint [3] 0 0
Screening to Day 252 (week 36)
Secondary outcome [4] 0 0
Immunogenicity presence and titers of ADAs and presence of nAbs against AVT03 and Prolia
Timepoint [4] 0 0
Time Frame: Day 1(week 1) to Day 252 (week 36)

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
Minimum age
28 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
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

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 assessing the outcomes
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
29/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/10/2023
Sample size
Target
Accrual to date
Final
209
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network - Herston
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchuch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
South Africa
State/province [3] 0 0
Bloemfontein

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alvotech Swiss AG
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05126784
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Felicitas Bullo
Address 0 0
Alvotech
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