Status:
COMPLETED
Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab)
Lead Sponsor:
Alvotech Swiss AG
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study has been designed as a multicentre, randomised, double-blind study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 compared to EU-Humira a...
Detailed Description
AVT02 is being developed as a biosimilar to Humira. EU-Humira and US-Humira have therefore been selected as the active control groups in this study. This study is designed as a multi-center, randomis...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female healthy adult subjects willing to sign a patient information and consent form (PICF) and able to undergo protocol related procedures.
- Age: 18 to 55 years, inclusive.
- Body Mass Index (BMI): 18.5 to 32.0 kg/m2.
- No history or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator would pose a risk to subject safety.
- Resting supine systolic blood pressure of ≤150 mmHg and diastolic blood pressure of ≤90 mmHg. Other vital signs showing no clinically relevant deviations according to the investigator's judgment.
- 12-lead ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the investigator.
- Negative urine drug screen and negative alcohol breath test at screening and admission.
- Exclusion Criteria
- Subjects will be excluded from the study if one or more of the following criterion are applicable:
- Evidence of clinically relevant pathology
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agent(s) used in study.
- Known history of previous exposure to adalimumab or other anti TNF-alpha molecules.
- Subjects with a recent (within 6 months of dosing) infection requiring hospitalisation or intravenous antibiotic use.
- Subjects with a recent (within 4 weeks of dosing) infection requiring oral or systemic antibiotics.
- Subject with a history of recurrent or chronic infections.
- Subject has a positive test for tuberculosis (TB) during screening or a known history of active or latent TB, except documented and complete adequate treatment of TB.
- Having received live vaccines during the 4 weeks before screening or have the intention to receive vaccination during the study.
- Participation in a drug study within 60 days or 5 half-lives of the previous drug (if known), whichever is longer, prior to drug administration Note: Only the few inclusion/exclusion criteria are mentioned here. Subjects will be screened and randomized as per the full list of inclusion and exclusion criteria in the protocol.
Exclusion
Key Trial Info
Start Date :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2020
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT03849313
Start Date
March 20 2019
End Date
February 17 2020
Last Update
May 4 2022
Active Locations (3)
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1
Scientia Clinical Research
Sydney, New South Wales, Australia, 2031
2
Christchurch Clinical Studies Trust Limited
Christchurch, Chistchurch, New Zealand, 8011
3
Auckland Clinical Studies
Auckland, New Zealand