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NCT06951880

A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers

Recruiting
PHASE1Ages 18–55InterventionalTreatment
AstraZeneca
~160 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:AZD4916Placebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over From Screening (Day -29 to Day -2) up to 44 days

Conditions

Healthy Participants

Explore related trials

Healthy Volunteers

NCT06951880

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Glendale, Californiano site contact published

    Recruiting

  • Research Site

    Harrow, United Kingdomno site contact published

    Withdrawn

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
All females must have negative pregnancy test and females of childbearing potential must not be lactating and must agree to use an approved method of highly effective contraception.
Have a Body Mass Index between 18 and 30 kg/m2 inclusive and weigh at least 45 kg at Screening.
Part 2, Japanese participants only: Japanese participants must have been born in Japan, have 2 Japanese biological parents and 4 Japanese grandparents (as confirmed by the interview), and must not have lived outside of Japan for more than 10 years at the time of the Screening Visit.
Part 2, Chinese participants only: Chinese participants must have been born in China (including Hong Kong, Macau, and Taiwan), have 2 Chinese biological parents and 4 Chinese grandparents (as confirmed by the interview), and must not have lived outside of China for more than 10 years at the time of the Screening Visit.

Exclusion

History of any clinically important disease or disorder which, in the opinion of the Principal 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 chest irradiation, fibrosis, malignancy, surgical procedure, trauma or liver disease.
Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
Evidence of active tuberculosis or Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection.
Abnormal vital signs or clinically important abnormalities in rhythm.
Current smokers, known or suspected history of alcohol, drug abuse or caffeine intake.
History of severe allergy/hypersensitivity.
Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss \> 500 mL during the 3 months prior to the Screening Visit.
Participants who are vegans or have dietary restrictions.
Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.

What this trial measures

  • Number of participants with adverse events (AEs)From Screening (Day -29 to Day -2) up to 44 days

    The safety and tolerability of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses to healthy participants (including Japanese and Chinese) will be assessed.