AVT03 With Xgeva in Healthy Male Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-21

Study Completion Date

2024-04-15

Brief Summary

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This study has been designed as a randomized, double-blind, parallel-group study and in healthy adult male subjects of age 28 years to 55 years old. The study will assess the PK, safety and tolerability of AVT03 compared to US-Xgeva when administered as a single 120 mg SC dose

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Detailed Description

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The study will consist of screening period, a 196 day (28 weeks) treatment and assessment period, and an End of Study (EOS) visit on week 32 on Day 196. Subjects will undertake a screening visit between Day -28 and Day -1 to determine their eligibility for 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 120mg AVT03 or 120mg Xgeva as subcutaneous injection.

Conditions

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This is a Phase I Study Conducted in Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double Blind

Study Groups

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Experimental Arm AVT03 120mg

AVT03 is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm will receive a single 120mg dose of AVT03 as a subcutaneous injection

Group Type EXPERIMENTAL

AVT03

Intervention Type BIOLOGICAL

AVT03 will be given as 1 time subcutaneous injection

Active Comparator Xgeva 120mg

Xgeva (denosumab) is the proposed active comparator for AVT03. Subjects in this arm will receive a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection

Group Type ACTIVE_COMPARATOR

Denosumab

Intervention Type BIOLOGICAL

Xgeva (denosumab) will be given as 1 time subcutaneous injection

Interventions

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AVT03

AVT03 will be given as 1 time subcutaneous injection

Intervention Type BIOLOGICAL

Denosumab

Xgeva (denosumab) will be given as 1 time subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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AVT03 proposed Biosimilar to Denosumab Xgeva

Eligibility Criteria

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Inclusion Criteria

1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
2. Male subjects who are 28 to 55 years old, inclusive, at the time of signing the ICF.
3. Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index of 17.0 to 32 kg/m2 at Screening and Day -1.

Exclusion Criteria

1. 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,, non-controlled hyperthyroidism 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, malabsorption syndrome.
2. Have osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery) or intend to undergo such procedures during the study period, poor oral hygiene, periodontal, and/or pre-existing dental disease.
3. Have bone fractures, presence of active healing fractures, or recent bone fracture
4. Abnormal serum calcium.
5. Known vitamin D deficiency.

Minimum Eligible Age

28 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes