Status:
NOT_YET_RECRUITING
A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Parexel
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants.
Detailed Description
This is a single-blind, placebo-controlled study conducted at a single clinical unit. The study will comprise of: * Part 1: Single ascending dose (SAD) part (part 1a) and a Multiple ascending dose (...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
June 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 24 2026
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT06951880
Start Date
June 27 2025
End Date
September 24 2026
Last Update
April 30 2025
Active Locations (1)
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1
Research Site
Harrow, United Kingdom, HA1 3UJ