Healthy ParticipantsPhase 1NCT06951880
A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers
A Phase 1 study testing AZD4916 in people with Healthy Participants, run by AstraZeneca at 2 sites in 2 countries.
Trial summary
The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD4916
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Jul 2026to 20 Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Research Site
Glendale, California, 91206
About this study
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)
The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- AZD4916, Placebo
- Keywords
- Single-ascending dose, Multiple-ascending dose, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4916Drug
AZD4916 will be administered as oral solution.
PlaceboOther
Placebo will be administered as oral solution.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised.
Measured: 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)
The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised.
Measured: 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)
The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised.
Measured: Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24
Maximum observed drug concentration (Cmax)
The single-dose and steady-state PK of AZD4916 following oral administration of single-ascending doses and multiple-ascending doses of AZD4916 to healthy volunteers (including Japanese and Chinese healthy volunteers) will be characterised.
Measured: Part 1a and 2a: Up to Day 8, Part 1b and 2b: Up to Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start23 Jul 2026
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951880
- Sponsor's protocol ID
- D7340C00001
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.