A First-in-human Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry.

  • STATUS
    Recruiting
  • participants needed
    48
  • sponsor
    AstraZeneca
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Updated on 16 February 2024
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body mass index

Summary

This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of single ascending doses (SAD) of AZD2373 in healthy male subjects of African ancestry.

Description

This study will be conducted as a single-centre, randomised, placebo-controlled, single-blind study to assess the effect of AZD2373 following ascending dose sequential group design administrations to healthy male subjects of African ancestry. The study will include 6 single dose cohorts with the option to include 2 additional cohorts based on emerging data from preceding cohorts in the study.

Approximately 48 male subjects aged 18 to 50 years at the time of informed consent (inclusive) will be randomized with the aim to have 8 subjects participate in each cohort. Within each cohort, 6 subjects will receive AZD2373 and 2 subjects will receive placebo.

Sentinel dosing will be applied for each cohort and will be divided into 2 groups:

  • Group 1 (sentinel group): 1 active, 1 placebo;
  • Group 2 (the rest of the cohort): 5 active, 1 placebo. The safety data of up to 72 hours post-dose in Group 1 will be reviewed by the Principal Investigator (PI) before the subjects in Group 2 are dosed.

The study will comprise:

  • A Screening Period of maximum 28 days;
  • A Treatment Period during which subjects will be resident at the Clinical Unit from the day before investigational medicinal product (IMP) administration (Day 1) until at least 72 hours after IMP administration; discharged from the Clinical Unit on Day 4;
  • Follow-up Visits on 1, 1.5, 2, 3, 4, 5, 6, and 8 weeks (Visits 3 to 10); and
  • A Final Follow up Visit 10 weeks after the last IMP dose.

The expected duration for any subject participating in the study is approximately 10 weeks (excluding an up to 28-day Screening Period).

Details
Condition Healthy Volunteers
Age 18years - 50years
Treatment Placebo, AZD2373 subcutaneous injection
Clinical Study IdentifierNCT04269031
SponsorAstraZeneca
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy male subjects of West African ancestry aged 18 to 50 years (inclusive, at time of informed consent) with suitable veins for cannulation or repeated venipuncture
Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive)
Provision of signed, written and dated informed consent for study participation which includes mandatory genotyping (study objective). NOTE: If a subject would decline to participate in the mandatory genotyping component of the study, the subject will not be included in the study

Exclusion Criteria

Subjects with known ancestry outside of West Africa
History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Any clinically important illness, medical/surgical procedure or trauma within 4 weeks prior to administration of IMP on Study Day 1
Any laboratory values with the following deviations
Alanine aminotransferase or aspartate aminotransferase greater than upper limit of normal and clinically significant as determined by the PI
White blood cell (WBC) count < 3.5 x10^9/L
Hemoglobin (Hb) below lower limit normal
Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results, other than those described above, as judged by the PI
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