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Unknown

AZD2373 subcutaneous injection for Healthy Subjects

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)
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and well tolerated in healthy male participants of sub-Saharan West African ancestry. The study will also look at how the drug is processed by the body.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,286 Previous Clinical Trials
288,620,026 Total Patients Enrolled
ParexelIndustry Sponsor
305 Previous Clinical Trials
101,090 Total Patients Enrolled
~8 spots leftby Jun 2025
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