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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAstraZeneca

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • AZD4916
  • Placebo

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

AstraZeneca

Lead sponsor

Parexel

Collaborator