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A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants

NCT05143905

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Safety, Tolerability, Pharmacokinetics, Healthy Participants

Interventions: AZD7503, Placebo

Countries: United States

This study will evaluate safety, tolerability and pharmacokinetics (PK) of AZD7503, following subcutaneous (SC) administration of single ascending doses of AZD7503 in healthy participants.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Healthy non smoking male and/or female (of non childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
* Females must have a negative pregnancy test at screening and on admission to the study centre, must not be lactating and must be of non childbearing potential.
* Body mass index (BMI) between 18 and 30 kg/m\^2, inclusive, and weigh at least 60 kg for healthy participants or between 18 and 32 kg/m\^2, inclusive, and weigh at least 50 kg for Japanese and Chinese participants.
* For Japanese and Chinese participants:

  1. A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes first-, second-and third-generation Japanese whose parents or grandparents are living in a country other than Japan.
  2. A Chinese participant is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes first-, second-and third-generation Chinese whose parents or grandparents are living in a country other than China.
* Willing to participate in retrospective genotyping analysis for HSD17B13.

Exclusion Criteria:

* History of any clinically important disease or disorder.
* 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 of administration of study intervention.
* Any laboratory values with the following deviations at screening and/or Day 1:

  * Alanine aminotransferase \> Upper Limit of Normal (ULN)
  * Aspartate aminotransferase \> ULN
  * Total bilirubin \> ULN
  * Creatinine \> ULN
  * White blood cell count \< Lower Limit of Normal (LLN)
  * Hemoglobin \< LLN
  * Estimated glomerular filtration rate \< 60 mL/min/1.73 m\^2
  * Platelets \>ULN and/or \<LLN.
* Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results other than those described above, including participants with platelet or bleeding disorders, known platelet dysfunction disorders.
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or Human Immunodeficiency Virus.
* Confirmed coronavirus disease 2019 (COVID-19) infection during screening and/or admission by polymerase chain reaction (PCR) test.
* Abnormal vital signs, after 5 minutes supine rest
* Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
* 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
* History of Drug abuse or positive screen for drug of abuse or cotinine (nicotine) or alcohol.
* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7503.
* Excessive intake of caffeine containing drinks or food (eg, coffee, tea, chocolate)
* Use of any prescribed or non prescribed medication during the 2 weeks prior to the administration of study intervention or longer if the medication has a long half-life.
* Plasma donation within one month of screening or any blood donation/blood loss more than 500 mL during the 3 months prior to screening.
* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days (or 5 half lives, whichever is longer) of the administration of study intervention in this study.
* Any ongoing or recent (ie, during the screening period) minor medical complaints.
* Previous bone marrow transplant.
* Non leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
Locations (1)
  • Glendale, California, United States