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

NCT06951880 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: D7340C00001
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants.

Conditions

Healthy Participants

Keywords

Single-ascending dose; Multiple-ascending dose; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs)

  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.

  From Screening (Day -29 to Day -2) up to 44 days

Secondary Outcomes (4)

• Area under concentration-time curve from time zero to infinity (AUCinf)

  Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24

• Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

  Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24

• Area under concentration-time curve in the dosing interval (AUCtau)

  Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24

• Maximum observed drug concentration (Cmax)

  Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24

Study Arms (2)

AZD4916

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

AZD4916 DRUG

AZD4916 will be administered as oral solution.

AZD4916

Placebo OTHER

Placebo will be administered as oral solution.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): September 24, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

GB (1)