A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers
A Phase I, Randomized, Single-blind, Placebo-controlled, 2-Part Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD4916 Following Single- and Multiple-ascending-dose Administration to Healthy Adult Volunteers (Including Japanese and Chinese Healthy Volunteers)
- Healthy Participants
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- AstraZeneca
- Enrolment target
- 160
- Started
- 23 July 2026
- Main results due
- 20 December 2027
- Study sites
- 2
- Registry updated
- 28 September 2026
Can you take part?
- Ages 18 years to 55 years.
- Open to any sex.
- Healthy volunteers can take part.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Main Inclusion Criteria: * 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. Main Exclusion Criteria: * 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 study is about
In the sponsor’s own words, from the registry.
The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants.
Study sites(2)
Research Site
Glendale, California, United States
Recruiting
Research Site
Harrow, United Kingdom
Withdrawn
Showing 2 of 2 sites. 1 of the 2 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06951880. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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