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Clinical Trial Summary

This study has been designed as a multicentre, randomised, double-blind study of AVT03 in healthy adult Male subjects. The study will assess the PK, PD safety and tolerability of AVT03 compared to Prolia when administered as a single 60 mg SC dose

Clinical Trial Description

This study is a (First In Human)FIH, multicenter, randomized, double-blinded, 2-arm, parallel-group study of AVT03 compared with Prolia when administered as a single 60 mg SC injection in healthy adult male subjects. The study will consist of a 4 week Screening period, a 28-week treatment and assessment period, and an End of Study (EOS) visit on Day 196. Subjects will undertake a Screening visit between Day -28 and Day -1 to determine their eligibility in the study. Subjects who meet the eligibility criteria will be admitted to the study site on the day prior to dosing (Day -1), during which their continued eligibility will be assessed up to Day 1 prior to dosing. On Day 1, eligible subjects will be randomized and will receive a single dose of AVT03 or Prolia. Subjects will receive adequate calcium and vitamin D supplements during the study as required (based on the Investigator's discretion), starting from Screening to ensure subjects have appropriate levels of these parameters at the time of IP administration. A staggered sentinel dosing strategy will be implemented as a safety measure, with equal numbers of subjects randomized to each treatment in a 1:1 ratio: Sentinel Group 1 (n = 2 subjects [1 per group]), Sentinel Group 2 (n = 4 subjects [2 per group]), and Sentinel Group 3 (n = 6 subjects [3 per group]). Following investigational product (IP) administration, there will be at least 72 hours of close observation and safety monitoring by the Investigator for each subject and between sentinel groups (ie, at least 72 hours should have elapsed following IP administration for the last subject in each sentinel group). Provided no significant safety or tolerability concerns (or events that meet the study stopping criteria) have been identified in the previous sentinel group following a safety review and discussion between the Investigator, Medical Monitor, and Sponsor Medical Lead, the next sentinel group of subjects will be randomized and dosed. Once the IP dose is deemed to be safe and well tolerated in all 3 sentinel groups, the remaining subjects (n = 194 [94 per group]) will be randomized and dosed. Sentinel subjects will remain confined to the study site from Day -1 to Day 4 (72 hours postdose); all remaining subjects will be confined to the study site from Day -1 up to Day 3 (48 hours postdose). Following dosing, PK, PD, safety, tolerability, and other assessments will be performed according to the Schedule of Assessments (Table 1). Subjects will return to the study site on an outpatient basis daily up to Day 12, then once a week from Day 15 to Day 29, followed by once approximately every 2 weeks up to Day 141, and finally on Day 196 for the EOS visit. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05126784
Study type Interventional
Source Alvotech Swiss AG
Status Not yet recruiting
Phase Phase 1
Start date May 30, 2022
Completion date June 30, 2023

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