Recruiting
Phase 1

AZD4916

Sponsor:

AstraZeneca

Code:

NCT06951880

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

AZD4916

Placebo

Study Details

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

Study ID

NCT06951880

Start date

Jul 23, 2026

Status verified date

Aug, 2026

Completion date

Dec 20, 2027

Anticipated

Primary completion date

Dec 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

AZD4916

AZD4916 will be administered as oral solution.

Placebo

Placebo will be administered as oral solution.

Primary outcome measure

  • Number of participants with adverse events (AEs) [ Time Frame: From Screening (Day -29 to Day -2) up to 44 days ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Glendale, California, United States, 91206

More Information

Sponsor

AstraZeneca

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Single-ascending dose
  • Multiple-ascending dose
  • Pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-26.