Clinical trial NCT06951880: A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Single-ascending dose
Multiple-ascending dose
Pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2025-04-30
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 (MAD) part (part 1b), both in global participants.
* Part 2: SAD part (part 2a) and a MAD part (part 2b) specifically for Japanese and Chinese participants only.

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.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: From Screening (Day -29 to Day -2) up to 44 days
Secondary outcomes:
measure: Area under concentration-time curve from time zero to infinity (AUCinf)
timeFrame: Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24
measure: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
timeFrame: Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24
measure: Area under concentration-time curve in the dosing interval (AUCtau)
timeFrame: Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24
measure: Maximum observed drug concentration (Cmax)
timeFrame: Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: Research Site
Study officials:
References: