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.
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT04269031
- Run by
- AstraZeneca
- People needed
- 30
- Starts
- 2020-02-13
- Expected to finish
- 2021-08-31
- Last updated by the study team
- 2023-07-10
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male subjects of West African ancestry aged 18 to 55 years (inclusive, at time of informed consent) with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 18 and 35 kg/m\^2 (inclusive) and weigh at least 50 kg and no more than 120 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.
You may not qualify if…
- 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 < 3.0 x 10\^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.
Where it is running
- Research Site — Brooklyn, Maryland, United States
Full record on ClinicalTrials.gov
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