AVT03 With Prolia in Healthy Male Subjects

NCT05126784
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Phase
Phase 1
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Recruitment status
Completed
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Participants
209
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Lead sponsor
Alvotech Swiss AG
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Start date
2022-06-29
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Number of sites
4
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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.
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Short title
AVT03 With Prolia in Healthy Male Subjects
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2023-10-16
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First posted
2021-11-19
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Registry last updated
2024-05-29
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Primary completion date
2023-10-16
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Start date
2022-06-29
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Actual participants
209
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Participants
209
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Participant count basis
Actual
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Protocol amendments
7
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Number of sites
4
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Alvotech Swiss AG
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05126784
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ClinicalTrials.gov ID
NCT05126784
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Other
Masking
Quadruple masking
Masking description
Double Blind
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

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

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

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

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

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

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

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

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

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

  1. PD_AUCE0 for CTX-1 (% inhibition)

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

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

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

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

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

  3. Safety incidence, nature and severity of adverse events

    Timeframe: Screening to Day 252 (week 36)

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

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

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

Sources for outcomes
clinicaltrials.gov

Sex
Male
Age groups
Adults
Minimum age
28 Years
Maximum age
55 Years
Healthy volunteers
Yes

  • 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

  • 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
Sources for eligibility
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  • Nucleus NetworkHerston, Australia
  • NZCR ChristchurchChristchurch, New Zealand
  • NZCR AucklandAuckland, New Zealand
  • FarmovsBloemfontein, South Africa
Sources for sites
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Sources for references
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Related records

Drugs (1)

Lead sponsors (1)

Targets (1)