A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers

Study Purpose

A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 55 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
  • - All females must have a negative pregnancy test.
  • - Females of childbearing potential must not be lactating and, if heterosexually active agree to an approved method of highly effective contraception.
  • - BMI between 18 and 32 kg/m^2 and weigh at least 45 kg.

Exclusion Criteria:

  • - Has received another new chemical entity.
  • - History of any disease or disorder which may put participant at risk in the study.
  • - Current or recurrent disease of clinical significance.
  • - Medical history of malignancies except for cervical carcinoma and non-melanoma skin cancer (NMSC) - Any clinically important illness, medical/procedure, or trauma.
  • - Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis result at screening.
  • - Any positive result on screening for serum hepatitis B surface antigen (HbsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) - History of latent or active tuberculosis (TB) or exposure to endemic areas.
  • - Evidence of active TB or untreated/inadequately/inappropriately treated for latent TB.
  • - Positive testing for Covid-19 prior to dosing, case of Covid-19 within 4 weeks, or long-term Covid-19-related sequelae.
  • - Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever.
  • - Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram (ECG), and any clinically important abnormalities in the 12-lead ECG.
  • - Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06103877
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AstraZeneca
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Healthy Volunteers
Additional Details

This is a first time in human (FTiH), placebo-controlled, sequential study in healthy participants. This study consists of two parts: Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD). Part 1 will contain 9 cohorts, 8 intravenously (IV) administered dose levels and 1 subcutaneously (SC) administered dose level of AZD1163. Part 2 will contain 2 SC dose levels of AZD1163. A sentinel dosing approach will be taken. Each participant will be involved in the study for approximately 70 weeks. The study will comprise of:

  • - A Screening Period of maximum 28 days for both Part 1 and Part 2.
  • - Part 1: A single dose of AZD1163 with an in-clinic period of 7 to 8 days.
  • - Part 2: Two doses of AZD1163, given 2 weeks apart both with an in-clinic period of 7 to 8 days.
  • - An outpatient Follow-up Period of approximately 15 months.

Arms & Interventions

Arms

Active Comparator: Part 1 Cohort 1 SAD

Participants will receive IV infusion of AZD1163 on Day 1.

Active Comparator: Part 1 Cohort 2 SAD

Participants will receive IV infusion of AZD1163 on Day 1.

Active Comparator: Part 1 Cohort 3 SAD

Participants will receive IV infusion of AZD1163 on Day 1.

Active Comparator: Part 1 Cohort 4 SAD

Participants will receive IV infusion of AZD1163 on Day 1.

Active Comparator: Part 1 Cohort 5a SAD

Participants will receive IV infusion of AZD1163 on Day 1.

Active Comparator: Part 1 Cohort 5b SAD

Participants will receive SC injection of AZD1163 on Day 1.

Active Comparator: Part 1 Cohort 6 SAD

Participants will receive IV infusion of AZD1163 on Day 1.

Active Comparator: Part 1 Cohort 7 SAD

Participants will receive IV infusion of AZD1163 on Day 1.

Active Comparator: Part 1 Cohort 8 SAD

Participants will receive IV infusion of AZD1163 on Day 1.

Placebo Comparator: Part 1 pooled Placebo SAD IV

Participants will receive matching IV infusion of placebo on Day 1.

Placebo Comparator: Part 1 pooled Placebo SAD SC

Participants will receive matching SC injection of placebo on Day 1.

Active Comparator: Part 2 Cohort 1 MAD (Japanese participants)

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Active Comparator: Part 2 Cohort 2 MAD (Japanese participants)

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Active Comparator: Part 2 Cohort 1 MAD (Chinese participants)

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Active Comparator: Part 2 Cohort 2 MAD (Chinese participants)

Participants will receive SC injection of AZD1163 on Days 1 and 15.

Placebo Comparator: Part 2 Placebo MAD (Japanese participants)

Participants will receive matching SC injection of placebo on Days 1 and 15.

Placebo Comparator: Part 2 Placebo MAD (Chinese participants)

Participants will receive matching SC injection of placebo on Days 1 and 15.

Interventions

Biological: - AZD1163

In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1. In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15.

Other: - Placebo

In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1. In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site, Glendale, California

Status

Recruiting

Address

Research Site

Glendale, California, 91206

Research Site, Brooklyn, Maryland

Status

Not yet recruiting

Address

Research Site

Brooklyn, Maryland, 21225

International Sites

Research Site, Berlin, Germany

Status

Not yet recruiting

Address

Research Site

Berlin, , 14050