A Study to Assess the Safety and Tolerability of Single Doses of AZD4076 in Healthy Male Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis (NASH)

In brief

This is a first-in-human (FIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD4076 tetracosasodium in healthy male subjects at increasing single doses

Key facts

Study ID

NCT02612662

Run by

AstraZeneca

People needed

40

Starts

2015-11-24

Expected to finish

2025-10-27

Last updated by the study team

2025-11-19

Who can join

Age: 18 and older, up to 50. 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 aged 18 - 50 years 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 optional genetic research

You may not qualify if…

• History or presence of any clinically significant 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 hepatic or renal disease, or any other condition known to interfere with distribution, metabolism, or excretion of drugs
• History or presence of significant neurological or psychiatric disease/mental illness (as judged by the investigator)
• Suspicion of or known Gilbert's syndrome based on liver function tests
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of IMP
• Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator
• Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV)
• Serum Creatinine greater than the ULN.
• Platelet count outside the normal range.
• AST, ALT, or GGT greater than the ULN.
• Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
• Systolic BP (SBP) < 90mmHg or ≥ 140 mmHg
• Diastolic BP (DBP) < 50mmHg or ≥ 90 mmHg
• Pulse < 45 or > 85 beats per minute (bpm)
• 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, particularly in the protocol defined primary lead or left ventricular hypertrophy
• Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome
• PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation)
• PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree AV block, or AV dissociation
• Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of, for example, ventricular hypertrophy or pre-excitation
• Known or suspected history of drug abuse, as judged by the investigator
• Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening
• History of alcohol abuse or excessive intake of alcohol, as judged by the investigator
• Positive screen for drugs of abuse or cotinine (nicotine) at screening or admission to the unit or positive screen for alcohol on admission to the unit prior to the administration of IMP
• History of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4076 tetracosasodium
• Excessive intake of caffeine containing drinks or food (e.g., coffee, tea), as judged by the investigator

Where it is running

• Research Site — Brooklyn, Maryland, United States

Full record on ClinicalTrials.gov

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