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

NCT06103877 | Completed Phase 1 FDA Drug

• 1 other identifier: D9640C00001
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Rheumatoid arthritis; Pharmocokinetics; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs)

  To assess the safety and tolerability of single and multiple ascending doses of AZD1163 following IV or SC administration.

  From Day -1 until end of study (Day 450)

Secondary Outcomes (6)

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

  Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450

• Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)

  Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450

• Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

  Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450

• Volume of distribution (apparent) at steady state following extravascular administration (Vz/F)

  Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450

• Maximum observed plasma (peak) drug concentration (Cmax)

  Part 1: Days 1-8, 11, 15, 22, 29, 57, 113, 225, 281, 365, 450; Part 2: Days 1-8, 11, 15-16, 22, 29, 57, 113, 225, 281, 365, 450

Study Arms (20)

Part 1 Cohort 1 SAD

ACTIVE COMPARATOR

Participants will receive IV infusion of AZD1163 on Day 1.

Biological: AZD1163

Part 1 Cohort 2 SAD

ACTIVE COMPARATOR

Participants will receive IV infusion of AZD1163 on Day 1.

Biological: AZD1163

Part 1 Cohort 3 SAD

ACTIVE COMPARATOR

Participants will receive IV infusion of AZD1163 on Day 1.

Biological: AZD1163

Part 1 Cohort 4 SAD

ACTIVE COMPARATOR

Participants will receive IV infusion of AZD1163 on Day 1.

Biological: AZD1163

Part 1 Cohort 5a SAD

ACTIVE COMPARATOR

Participants will receive IV infusion of AZD1163 on Day 1.

Biological: AZD1163

Part 1 Cohort 5b SAD

ACTIVE COMPARATOR

Participants will receive SC injection of AZD1163 on Day 1.

Biological: AZD1163

Part 1 Cohort 6 SAD

ACTIVE COMPARATOR

Participants will receive IV infusion of AZD1163 on Day 1.

Biological: AZD1163

Part 1 Cohort 7 SAD

ACTIVE COMPARATOR

Participants will receive IV infusion of AZD1163 on Day 1.

Biological: AZD1163

Part 1 Cohort 8 SAD

ACTIVE COMPARATOR

Participants will receive IV infusion of AZD1163 on Day 1.

Biological: AZD1163

Part 1 Pooled Placebo SAD IV

PLACEBO COMPARATOR

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

Other: Placebo

Part 1 Placebo SAD SC

PLACEBO COMPARATOR

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

Other: Placebo

Part 1 Cohort 9 SAD (Chinese Participants)

ACTIVE COMPARATOR

Participants will receive SC injection of AZD1163 on Day 1.

Biological: AZD1163

Part 1 Placebo SAD (Chinese Participants)

PLACEBO COMPARATOR

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

Other: Placebo

Part 2 Cohort 1 MAD (Global)

ACTIVE COMPARATOR

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

Biological: AZD1163

Part 2 Cohort 2 MAD (Global)

ACTIVE COMPARATOR

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

Biological: AZD1163

Part 2 Placebo MAD (Global)

PLACEBO COMPARATOR

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

Other: Placebo

Part 2 Cohort 3 MAD (Chinese Participants)

ACTIVE COMPARATOR

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

Biological: AZD1163

Part 2 Cohort 4 MAD (Japanese participants)

ACTIVE COMPARATOR

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

Biological: AZD1163

Part 2 Placebo MAD (Chinese participants)

PLACEBO COMPARATOR

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

Other: Placebo

Part 2 Placebo MAD (Japanese participants)

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

AZD1163 BIOLOGICAL

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.

Part 1 Cohort 1 SAD; Part 1 Cohort 2 SAD; Part 1 Cohort 3 SAD; Part 1 Cohort 4 SAD; Part 1 Cohort 5a SAD; Part 1 Cohort 5b SAD; Part 1 Cohort 6 SAD; Part 1 Cohort 7 SAD; Part 1 Cohort 8 SAD; Part 1 Cohort 9 SAD (Chinese Participants); Part 2 Cohort 1 MAD (Global); Part 2 Cohort 2 MAD (Global); Part 2 Cohort 3 MAD (Chinese Participants); Part 2 Cohort 4 MAD (Japanese participants)

Placebo OTHER

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.

Part 1 Placebo SAD (Chinese Participants); Part 1 Placebo SAD SC; Part 1 Pooled Placebo SAD IV; Part 2 Placebo MAD (Chinese participants); Part 2 Placebo MAD (Global); Part 2 Placebo MAD (Japanese participants)

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 a negative pregnancy test
• Females of childbearing potential must not be lactating and, if heterosexually active, agree to taking approved method/s of contraception
• BMI between 18 and 32 kg/m\^2 and weigh at least 45 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (3)

Research Site

Glendale, California, 91206, United States

Location

Research Site

Brooklyn, Maryland, 21225, United States

Location

Research Site

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: November 1, 2023
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

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

DE (1); US (2)