Comparing the effects of AVT80 and Entyvio in healthy volunteers
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
This study is testing how safe and effective a new drug called AVT80 is compared to Entyvio in healthy volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 351 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Alvotech Swiss AG Industry-sponsored |
| Locations | 3 sites (Bayswater and 2 other locations) |
| Trial ID | NCT06732804 on ClinicalTrials.gov |
What this trial studies
This study is designed as a randomized, parallel-group, double-blind trial to compare the pharmacokinetics, safety, immunogenicity, and tolerability of AVT80 and Entyvio in healthy male and female subjects. Participants will undergo a screening period to determine eligibility and will then be randomized to receive a single dose of either AVT80 or one of two geographical variants of Entyvio. The study includes a treatment and assessment period followed by an End of Study visit to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 18 to 55 with a body weight between 50.0 to 90.0 kg and a BMI of 17.0 to 32.0 kg/m2.
Not a fit: Patients with a history of relevant drug or food allergies, hypersensitivity to Entyvio or AVT80, or any medical conditions that could interfere with the study will not benefit from participation.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and effectiveness of AVT80 compared to Entyvio, potentially leading to improved treatment options.
How similar studies have performed: While this study explores a comparative approach, similar studies have shown success in evaluating pharmacokinetics and safety profiles of new treatments.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Bayswater and 2 other locations
- Veritus Research Pty Ltd — Bayswater, Australia (Recruiting)
- Investigational Site 0002 — Auckland, New Zealand (Recruiting)
- Nzcr — Christchurch, New Zealand (Recruiting)
Study contacts
- Study coordinator: Richard Bucknall
- Email: alvotech.clinical@alvotech.com
- Phone: +41 78 659 8989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.