This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of AZD6234. This study will take place at one site in Nottingham, United Kingdom, and will enrol 21 healthy men and women aged 18-55 years.
This study in healthy volunteers aims to compare blood levels and side effects after administration of different formulations of AZD6234. This study will take place at one site in Nottingham, United Kingdom. It plans to enrol 21 healthy men and women aged 18-55 years. Each volunteer will take part in 4 treatment periods and receive different formulations of AZD6234, by injection under the skin into the abdomen (stomach). In each period they'll be given a single dose without food. They'll stay in the clinic for 6 nights on 4 occasions, attend up to 10 outpatient visits, and take up to 19 weeks to finish the study. Blood and urine samples will be collected to: measure the amount of AZD6234 and its breakdown products, do safety tests and assess the effect of the test medicine on the immune system response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
AZD6234 Formulation 1 will be administered as a single SC injection
AZD6234 Formulation 2 (low concentration) will be administered as a single SC injection
AZD6234 Formulation 2 (high concentration) will be administered as a single SC injection
Research Site
Ruddington, United Kingdom
Maximum observed plasma concentration (Cmax)
Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations
Time frame: Plasma sample collection from pre- dose to 30 days post final dose
Area under the concentration-time curve from time 0 to the time of the last measurable concentration (AUC0-t)
Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations
Time frame: Plasma sample collection from pre- dose to 30 days post final dose
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations
Time frame: Plasma sample collection from pre- dose to 30 days post final dose
Number of subjects with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests
Safety and tolerability of different AZD6234 SC formulations
Time frame: Through study duration, approximately 19 weeks
Time of maximum observed plasma concentration (tmax)
Pharmacokinetics (PK) of different AZD6234 SC formulations
Time frame: Plasma sample collection from pre- dose to 30 days post final dose
Terminal elimination half-life (t1/2)
Pharmacokinetics (PK) of different AZD6234 SC formulations
Time frame: Plasma sample collection from pre- dose to 30 days post final dose
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AZD6234 Formulation 3 will be administered as a single SC injection
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown (CL/F)
Pharmacokinetics (PK) of different AZD6234 SC formulations
Time frame: Plasma sample collection from pre- dose to 30 days post final dose
Volume of distribution based on the terminal phase calculated using AUC0-inf after a single extravascular administration where F (fraction of dose bioavailable) is unknown (Vz/F)
Pharmacokinetics (PK) of different AZD6234 SC formulations
Time frame: Plasma sample collection from pre- dose to 30 days post final dose