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NCT05876949 | COMPLETED | This is a Phase I Study Conducted in Healthy Volunteers

AVT03 With Xgeva in Healthy Male Subjects
Sponsor:

Alvotech Swiss AG

Brief Summary:

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

Condition or disease

This is a Phase I Study Conducted in Healthy Volunteers

Intervention/treatment

AVT03

Denosumab

Phase

PHASE1

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 208 participants
Masking : QUADRUPLE
Masking Description : Double Blind
Primary Purpose : OTHER
Official Title : A Randomized, Double-blind, Parallel Design, Single Dose, 2-arm Study Comparing the Pharmacokinetic, Safety and Immunogenicity Profiles of AVT03 and US-Xgeva® in Healthy Male Subjects
Actual Study Start Date : 2023-07-21
Estimated Primary Completion Date : 2024-04-15
Estimated Study Completion Date : 2024-04-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 28 Years to 55 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: 1
Criteria
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.
AVT03 With Xgeva in Healthy Male Subjects

Location Details

NCT05876949

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Poland,

Biokinetica

Józefów, Poland,

Not yet recruiting

South Africa,

Farmov

Bloemfontein, South Africa,

Not yet recruiting

United Kingdom,

Richmond Pharmacology

London, United Kingdom,