Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab)

• Status: Completed
• Trial end date: 2020-02-22
• Target enrollment: 0
• Participant gender: All

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 and US licenced Humira (US-Humira), when administered as a single 40 mg SC dose.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alvotech Swiss AG
• Treatments: Adalimumab

Criteria

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.