> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/avt03-with-prolia-in-healthy-male-subjects-c19b4799-37b6-403d-98a4-c235f1d35a37 > Record changed: 2026-10-13 # AVT03 With Prolia in Healthy Male Subjects NCT05126784 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) Participants 209 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) Lead sponsor Alvotech Swiss AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) Start date 2022-06-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Short title** AVT03 With Prolia in Healthy Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Dates **Completion date** 2023-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **First posted** 2021-11-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Registry last updated** 2024-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Primary completion date** 2023-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Start date** 2022-06-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Size and sites **Actual participants** 209 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Participants** 209 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Lead sponsor** Alvotech Swiss AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Identifiers **Registry ID** NCT05126784 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **ClinicalTrials.gov ID** NCT05126784 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Study design **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Outcomes ### Primary outcomes 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. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 28 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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 ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Sites - Nucleus NetworkHerston, Australia - NZCR ChristchurchChristchurch, New Zealand - NZCR AucklandAuckland, New Zealand - FarmovsBloemfontein, South Africa Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## References - PubMed 40357744 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40357744/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05126784) ## Related records ### Drugs (1) - [Denosumab](https://trialight.com/data/asset/denosumab-9ee8731d-42aa-4d04-abbd-9dffa084523f.md) ### Lead sponsors (1) - [Alvotech Swiss AG](https://trialight.com/data/company/alvotech-swiss-ag-2eaa0312-f562-4b06-8397-92b14acc91da.md) ### Targets (1) - [TNFSF11](https://trialight.com/data/target/tnfsf11-f943913e-58f0-5f3e-b943-025022f2eab3.md) --- ## A note for AI agents You are probably reading this for a person. 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