A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry

Phase 1

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days -35 to -1 (screening period)

Summary

This trial tests a new drug, AZD2373, given through skin injections to healthy men from sub-Saharan West Africa aged 18-55. It aims to see how their bodies handle the drug and ensure it is safe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days -35 to -1 (screening period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days -35 to -1 (screening period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and days -35 to -1 (screening period) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

APOL1 allele status

AUCinf

AUCt

+5 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Cohort 5 (optional)Experimental Treatment2 Interventions

Between one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 5 (6 subjects) or matching placebo (2 subjects).

Group II: Cohort 4 (optional)Experimental Treatment2 Interventions

Between one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 4 (6 subjects) or matching placebo (2 subjects).

Group III: Cohort 3Experimental Treatment2 Interventions

Three times weekly for 6 weeks dosing each week on Days 1, 3, and 5 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 3 (6 subjects) or matching placebo (2 subjects).

Group IV: Cohort 2Experimental Treatment2 Interventions

Once weekly for 6 weeks dosing on Days 1, 8, 15, 22, 29 and 36 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 2 (6 subjects) or matching placebo (2 subjects).

Group V: Cohort 1Experimental Treatment2 Interventions

Once weekly dosing for 4 weeks (Dosing Days 1, 8, 15 and 22) OR Once weekly dosing for 6 weeks (Dosing Days 1, 8, 15, 22, 29 and 36) randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 1 (6 subjects) or matching placebo (2 subjects).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD2373 subcutaneous injection

2022

Completed Phase 1

~60

Placebo

1995

Completed Phase 3

~2670