PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)

• Status: Completed
• Trial end date: 2019-11-15
• Target enrollment: 0
• Participant gender: All

Summary

This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in Autoinjector Pen. Both arms will use single dose of 40mg of AVT02 (Adalimumab)

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

Details

• Lead Sponsor: Alvotech Swiss AG
• Treatments: Adalimumab

Criteria

Inclusion Criteria:To be eligible for study entry, subjects must satisfy all of the following 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: 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 (BP) of ≤150 mmHg and diastolic BP 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;

• Subjects smokes <10 cigarettes per day within 3 months of screening and is able to abide by the smoking policy of the site;

• Ability and willingness to abstain from alcohol from 48 hours prior to IP administration, during confinement in the study site until discharge from the confinement period and 24 hours prior to ambulatory visits;

• Females must have a negative pregnancy test at screening and on admission to the study site, must not be lactating and must agree to sexual abstinence or the use effective contraception, starting at screening and continue throughout the study period up to the end of study (EOS) visit;

• Male subjects and their female spouse/partners who are of childbearing potential must agree to using 2 forms of birth control (1 of which is a highly effective method and 1 must be a barrier method), or agree to sexual abstinence, starting at screening and continue throughout the study period up to the EOS visit;

• Male subject must not donate sperm starting at screening and throughout the study period up to the EOS visit;

Exclusion Criteria:To be eligible for study entry, subjects must satisfy all of the following 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: 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 (BP) of ≤150 mmHg and diastolic BP 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;

• Subjects smokes <10 cigarettes per day within 3 months of screening and is able to abide by the smoking policy of the site;

• Ability and willingness to abstain from alcohol from 48 hours prior to IP administration, during confinement in the study site until discharge from the confinement period and 24 hours prior to ambulatory visits;

• Females must have a negative pregnancy test at screening and on admission to the study site, must not be lactating and must agree to sexual abstinence or the use effective contraception, starting at screening and continue throughout the study period up to the end of study (EOS) visit;

• Male subjects and their female spouse/partners who are of childbearing potential must agree to using 2 forms of birth control (1 of which is a highly effective method and 1 must be a barrier method), or agree to sexual abstinence, starting at screening and continue throughout the study period up to the EOS visit;

• Male subject must not donate sperm starting at screening and throughout the study period up to the EOS visit;