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

Study identifier:D7340C00001

ClinicalTrials.gov identifier:NCT06951880

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

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)

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD4916

Sex

All

Estimated Enrollment

178

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 27 Jun 2025

Estimated Primary Completion Date: 24 Sept 2026

Estimated Study Completion Date: 24 Sept 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2025 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria

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.
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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.
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No locations available

Arms	Assigned Interventions
Experimental: AZD4916 Parts 1a and 2a participants will receive a single oral dose of AZD4916 on Day 1. Parts 1b and 2b participants will receive a single oral dose of AZD4916 on Day 1 and multiple doses of AZD4916 on Days 4 through 17.	Drug: AZD4916 AZD4916 will be administered as oral solution.
Placebo Comparator: Placebo Parts 1a and 2a participants will receive a single oral dose of placebo on Day 1. Parts 1b and 2b participants will receive a single dose placebo on Day 1 and multiple doses of placebo on Days 4 through 17.	Other: Placebo Placebo will be administered as oral solution.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]