CompletedPhase 1

AVT03 With Xgeva in Healthy Male Subjects

Poland, South Africa, United Kingdom208 participantsStarted 2023-07-21

Plain-language 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

Who can participate

Age range28 Years – 55 Years

SexMALE

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Inclusion criteria

✓. 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.
✓. Male subjects who are 28 to 55 years old, inclusive, at the time of signing the ICF.
✓. 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

✕. 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.
✕. 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.
✕. Have bone fractures, presence of active healing fractures, or recent bone fracture
✕. Abnormal serum calcium.
✕. Known vitamin D deficiency.

What they're measuring

Co-primary PK Endpoint Cmax: Maximum Serum Concentration

Timeframe: Day 1 (pre-dose, 8h and 12h post-dose), Day 2 to Day 13 (daily), Day 15, Day 18, Day 22, Day 25, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 112, Day 126, Day 141, Day 162 and Day 196 (week 28) / End of study

Co-primary PK endpoint_AUC0-t: Area Under the Serum Concentration-time Curve up to Time t, Where t is the Last Time Point With a Concentration Above the Lower Limit of Quantitation

Trial details

NCT IDNCT05876949

SponsorAlvotech Swiss AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-15

Results submitted2025-04-11

View on ClinicalTrials.gov More This is a Phase I Study Conducted in Healthy Volunteers trials