This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of multiple ascending doses (MAD) of AZD2373 in healthy male participants of sub-Saharan West African ancestry.
This study will be conducted as a single center, randomized, placebo-controlled, single-blind study to assess the effect of AZD2373 following multiple ascending dose sequential group design administrations to healthy male participants of sub Saharan West African ancestry. The study will consist of up to 5 cohorts Up to 40 male participants aged 18 to 55 years (inclusive), at time of informed consent, will be randomized. The MAD study subjects will be selected based on the results of the pre-screening study with regards to APOL1 allele status. For all cohorts, 8 participants will participate in each cohort. The expected duration for any participant participating in the study is approximately 14 to 16 weeks, excluding an up to 35-day Screening Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Randomized subjects will receive multiple ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5).
Randomized subjects will receive a multiple ascending dose of placebo (saline solution) by SC injection.
Research Site
Brooklyn, Maryland, United States
Number of subjects with adverse events and/or abnormal findings in vital signs, and/or clinical laboratory assessments and/or physical examination and/or electrocardiogram (ECG) evaluation and/or injection site reactions
To assess the safety and tolerability of subcutaneous (SC) multiple ascending dose (MAD) administrations of AZD2373.
Time frame: Up to 21 weeks (From Screening to Final Visit)
AUCinf
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
AUCt
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
AUCτ
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
Cmax
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
tmax
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
t1/2
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percent change in plasma APOL1 protein from baseline
To assess the effect of SC MAD administrations of AZD2373 on plasma concentrations of APOL1 protein
Time frame: Up to 21 weeks (From Screening to Final Visit)
APOL1 allele status
To determine APOL1 G0, G1, G2 allele genotype status in all study participants
Time frame: Days -35 to -1 (Screening period)