Clinical trial NCT06732804: Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio
Official title: A Randomised, Parallel Group Treatment, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, Immunogenicity, and Tolerability Between AVT80 and Entyvio® in Healthy Male and Female Participants Aged 18 to 55 Years Inclusive
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Male and Female Subjects
Keywords: Pharmacokinetics
Lead sponsor: Alvotech Swiss AG
Sponsor class: INDUSTRY
First posted: 2024-12-13
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study has been designed as a randomised, parallel-group, double-blind, 3 arm study to investigate the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio in healthy volunteers.

Detailed description: The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to receive a single dose of either AVT80, geographical region 1 Entyvio or geographical region 2 Entyvio.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol.
* 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).
* Participant must be 18 to 55 years old inclusive, at the time of signing the ICF.

Exclusion Criteria:

* Participant has a history of relevant drug and/or food allergies.
* Participant has a history of hypersensitivity to Entyvio, AVT80, or their constituents.
* Participant has any past or concurrent medical conditions that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (e.g., demyelinating disorders).

Primary outcomes:
measure: To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio
timeFrame: Day Zero to Day 126
measure: To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio
timeFrame: Day Zero to Day 126
Secondary outcomes:
Other outcomes:
Locations:
city: Bayswater
country: Australia
facility: Veritus Research Pty Ltd
city: Auckland
country: New Zealand
facility: Investigational Site 0002
city: Christchurch
country: New Zealand
facility: NZCR
Study officials:
affiliation: Alvotech Swiss AG
name: Eveline Schurink
role: STUDY_DIRECTOR
References: