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Healthy Male SubjectsPhase 1NCT05126784

AVT03 With Prolia in Healthy Male Subjects

A Phase 1 study testing AVT03 and Prolia in people with Healthy Male Subjects, run by Alvotech Swiss AG at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 28 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Male Subjects
What is being tested?
AVT03 and Prolia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
209 participants
Where
4 sitesin 3 countries
Study dates
29 Jun 2022to 16 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 28 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

New Zealand2 sites

  • NZCR Auckland

    Auckland

  • NZCR Christchurch

    Christchurch, Christchuch

Other trials in New Zealand

Australia1 site

  • Nucleus Network

    Herston

Other trials in Australia

South Africa1 site

  • Farmovs

    Bloemfontein

Other trials in South Africa

About this study

Official 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

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.

Read the detailed description

The study will consist of a 4 week screening period, a 252 day (36 weeks) treatment and assessment period, and an End of Study (EOS) visit on week 36 on Day 252. Subjects will undertake a screening visit between Day -28 and Day -1 to determine their eligibility for the study. On Day 1, eligible subjects will be randomized and will receive a single dose of AVT03 or Prolia as subcutaneous injection.

Being tested
AVT03, Prolia
Keywords
Denosumab, Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVT03Biological

    Also called AVT03, Biosimilar Denosumab

    AVT03 (biosimilar to denosumab) will be given as single subcutaneous injection

  • ProliaBiological

    Also called Denosumab

    Prolia (denosumab) will be given as single subcutaneous injection

Study groups in NCT05126784
Study groupRoleWhat they receive
AVT03 ArmExperimentalAVT03 (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.
Receives: Biological: AVT03
Prolia ArmActive comparatorProlia(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.
Receives: Biological: Prolia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the serum concentration-time curve (AUC0-last) from day 0 to day 252

    Venous blood samples will be collected for measurement of Area under serum concentration-time curve (AUC 0-t) AVT03 and Prolia

    Measured: Day 1(week 1) to Day 252 (week 36)

  2. Area under the serum concentration-time curve (AUC0-inf) from day 0 to day 252

    Venous blood samples will be collected for measurement of CTX-1 serum biomarker for AVT03 and Prolia.

    Measured: Time Frame: Day 1(week 1) to Day 252 (week 36)]

  3. Maximum serum concentration Cmax from day 0 to day 252

    Venous blood samples will be collected for measurement of maximum serum concentration (Cmax) of AVT03 and Prolia.

    Measured: Day 1(week 1) to Day 252 (week 36)

Secondary outcomes (4)

  1. PD_AUCE0 for CTX-1 (% inhibition)

    Venous blood samples will be collected for measurement of serum concentration of AVT03 and Prolia

    Measured: Day 1(week 1) to Day 252 (week 36)

  2. PK area under the concentration-time curve (AUC0-24) from Day 0 to Day 252

    Venous blood samples will be collected for measurement of serum concentration of AVT03 and Prolia

    Measured: Day 1(week 1) to Day 162 (week 24)]

  3. Safety incidence, nature and severity of adverse events

    Measured: Screening to Day 252 (week 36)

  4. Immunogenicity presence and titers of ADAs and presence of nAbs against AVT03 and Prolia

    Venous blood samples will be collected for measurement of antidrug-antibodies against of AVT03 and Prolia

    Measured: Time Frame: Day 1(week 1) to Day 252 (week 36)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start29 Jun 2022
  3. Primary completion16 Oct 2023
  4. Study completion16 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Arm 1: AVT03 Arm 2: US-Prolia
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05126784
Sponsor's protocol ID
AVT03-GL-P01
Status last verified
May 2024
First submitted
1 Nov 2021
Last updated
29 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pretorius A, Bullo F, Jaskiewicz L, Stamatakos S, Otto H, Rai M, Ruffieux R, Sattar A, Leutz S, Berti F. A randomized, double-blind, single dose, parallel group, 2-arm study assessing the pharmacokinetic similarity, pharmacodynamic, safety, tolerability, and immunogenicity profiles of biosimilar candidate AVT03 (60 mg/mL) in healthy male adults. Expert Opin Investig Drugs. 2025 Jun;34(6):527-537. doi: 10.1080/13543784.2025.2505466. Epub 2025 May 16.

    PubMed 40357744

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AVT03 and Prolia in people with Healthy Male Subjects, run by Alvotech Swiss AG at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in New Zealand, Australia, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the serum concentration-time curve (AUC0-last) from day 0 to day 252 (time frame: Day 1(week 1) to Day 252 (week 36)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05126784, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.

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