A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West 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 multiple ascending doses (MAD) of AZD2373 in healthy male participants of sub-Saharan West African ancestry.

Key facts

Study ID

NCT05351047

Run by

AstraZeneca

People needed

24

Starts

2022-04-04

Expected to finish

2023-07-06

Last updated by the study team

2023-08-07

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 participants of sub-Saharan West African ancestry aged 18 to 55 years (inclusive, at time of informed consent)
• Have a BMI between 18.5 and 35 kg/m2 (inclusive) and weigh at least 50 kg and no more than 120 kg (inclusive) at screening.
• Provision of signed, written and dated informed consent and completed mandatory genotyping in the pre-screening study .

You may not qualify if…

• Participants with known ancestry outside of sub-Saharan West Africa.
• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant'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.
• History of any chronic skin disease, auto-immunological diseases and allergic diseases of any etiology.
• Any clinically important illness, medical/surgical procedure or trauma within 4 weeks prior to administration of IMP on Study Day 1.
• Participant has clinical signs and symptoms consistent with SARS-CoV-2 or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
• . 7. Participant who had a severe course of COVID-19.
• Participant has a positive viral RNA test result for SARS-CoV-2 before randomization.
• Any laboratory values with the following deviations:
• ALT or AST greater than ULN and clinically significant as determined by the PI.
• WBC count < 3.0 x 109/L.
• Hb below LLN.
• Total bilirubin > ULN.
• Platelet count below LLN.
• 10, Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results, as judged by the PI.
• Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV.
• Any abnormal vital signs, after 10 minutes supine rest.
• Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology.
• Known or suspected history of drug abuse as judged by the PI.
• Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months.
• History of alcohol abuse or excessive intake of alcohol as judged by the PI.
• Positive screen for drugs of abuse or cotinine (nicotine) at Screening or admission to the Clinical Unit or positive screen for alcohol on admission to the Clinical Unit prior to administration of the IMP on Study Day 1.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2373.
• Excessive intake of caffeine-containing drinks or food as judged by the PI.
• Use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, mega-dose vitamins or minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long t½..

Where it is running

• Research Site — Brooklyn, Maryland, United States

Full record on ClinicalTrials.gov

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