Healthy VolunteersPhase 1NCT06103877
A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
A Phase 1 study testing AZD1163 in people with Healthy Volunteers, run by AstraZeneca at 3 sites in 2 countries.
Trial summary
A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy 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 Volunteers
- What is being tested?
- AZD1163
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Nov 2023to 13 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Research Site
Brooklyn, Maryland, 21225
Research Site
Glendale, California, 91206
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AZD1163 Administered as Single and Multiple Ascending Doses in Healthy Volunteers
A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.
Read the detailed description
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.
- Conditions
- Healthy Volunteers
- Being tested
- AZD1163, Placebo
- Keywords
- Rheumatoid arthritis, Pharmocokinetics, Healthy volunteers
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1163Biological
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 SAD | Active comparator | Participants will receive IV infusion of AZD1163 on Day 1. Receives: Biological: AZD1163 |
| Part 1 Cohort 2 SAD | Active comparator | Participants will receive IV infusion of AZD1163 on Day 1. Receives: Biological: AZD1163 |
| Part 1 Cohort 3 SAD | Active comparator | Participants will receive IV infusion of AZD1163 on Day 1. Receives: Biological: AZD1163 |
| Part 1 Cohort 4 SAD | Active comparator | Participants will receive IV infusion of AZD1163 on Day 1. Receives: Biological: AZD1163 |
| Part 1 Cohort 5a SAD | Active comparator | Participants will receive IV infusion of AZD1163 on Day 1. Receives: Biological: AZD1163 |
| Part 1 Cohort 5b SAD | Active comparator | Participants will receive SC injection of AZD1163 on Day 1. Receives: Biological: AZD1163 |
| Part 1 Cohort 6 SAD | Active comparator | Participants will receive IV infusion of AZD1163 on Day 1. Receives: Biological: AZD1163 |
| Part 1 Cohort 7 SAD | Active comparator | Participants will receive IV infusion of AZD1163 on Day 1. Receives: Biological: AZD1163 |
| Part 1 Cohort 8 SAD | Active comparator | Participants will receive IV infusion of AZD1163 on Day 1. Receives: Biological: AZD1163 |
| Part 1 Pooled Placebo SAD IV | Placebo comparator | Participants will receive matching IV infusion of placebo on Day 1. Receives: Other: Placebo |
| Part 1 Placebo SAD SC | Placebo comparator | Participants will receive matching SC injection of placebo on Day 1. Receives: Other: Placebo |
| Part 1 Cohort 9 SAD (Chinese Participants) | Active comparator | Participants will receive SC injection of AZD1163 on Day 1. Receives: Biological: AZD1163 |
| Part 1 Placebo SAD (Chinese Participants) | Placebo comparator | Participants will receive matching SC injection of placebo on Day 1. Receives: Other: Placebo |
| Part 2 Cohort 1 MAD (Global) | Active comparator | Participants will receive SC injection of AZD1163 on Days 1 and 15. Receives: Biological: AZD1163 |
| Part 2 Cohort 2 MAD (Global) | Active comparator | Participants will receive SC injection of AZD1163 on Days 1 and 15. Receives: Biological: AZD1163 |
| Part 2 Placebo MAD (Global) | Placebo comparator | Participants will receive matching SC injection of placebo on Days 1 and 15. Receives: Other: Placebo |
| Part 2 Cohort 3 MAD (Chinese Participants) | Active comparator | Participants will receive SC injection of AZD1163 on Days 1 and 15. Receives: Biological: AZD1163 |
| Part 2 Cohort 4 MAD (Japanese participants) | Active comparator | Participants will receive SC injection of AZD1163 on Days 1 and 15. Receives: Biological: AZD1163 |
| Part 2 Placebo MAD (Chinese participants) | Placebo comparator | Participants will receive matching SC injection of placebo on Days 1 and 15. Receives: Other: Placebo |
| Part 2 Placebo MAD (Japanese participants) | Placebo comparator | Participants will receive matching SC injection of placebo on Days 1 and 15. 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)
To assess the safety and tolerability of single and multiple ascending doses of AZD1163 following IV or SC administration.
Measured: From Day -1 until end of study (Day 450)
Secondary outcomes (6)
Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)
To characterize the pharmacokinetics (PK) of AZD1163 following IV/SC administration of single and multiple ascending doses.
Measured: 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)
To characterize the PK of AZD1163 following IV/SC administration of single and multiple ascending doses.
Measured: 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)
To characterize the PK of AZD1163 following SC administration of single and multiple ascending doses.
Measured: 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)
To characterize the PK of AZD1163 following SC administration of single and multiple ascending doses.
Measured: 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)
To characterize the PK of AZD1163 following IV/SC administration of single and multiple ascending doses.
Measured: 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
Number of participants with positive anti-AZD1163 antibodies
To evaluate the immunogenicity of AZD1163.
Measured: Part 1: Day 1, 11, 29, 113, 225, 281, 365, 450; Part 2: Day 1, 15, 29, 57, 113, 281, 365, 450
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Nov 2023
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103877
- Sponsor's protocol ID
- D9640C00001
- Status last verified
- Jan 2026
- First submitted
- 23 Oct 2023
- Last updated
- 27 Jan 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of AZD1163 Administered as Single and Multiple Ascending Doses in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06103877
- Acronym / sponsor ID
- D9640C00001
- Conditions
- Healthy Volunteers
- Keywords
- Rheumatoid arthritis, Pharmocokinetics, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to demonstrate the safety and tolerability of AZD1163 when administered intravenously and subcutaneously in healthy participants.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 20
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 SAD | Active comparator | Biological: AZD1163Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 2 SAD | Active comparator | Biological: AZD1163Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 3 SAD | Active comparator | Biological: AZD1163Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 4 SAD | Active comparator | Biological: AZD1163Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 5a SAD | Active comparator | Biological: AZD1163Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 5b SAD | Active comparator | Biological: AZD1163Participants will receive SC injection of AZD1163 on Day 1. |
| Part 1 Cohort 6 SAD | Active comparator | Biological: AZD1163Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 7 SAD | Active comparator | Biological: AZD1163Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 8 SAD | Active comparator | Biological: AZD1163Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Pooled Placebo SAD IV | Placebo comparator | Other: PlaceboParticipants will receive matching IV infusion of placebo on Day 1. |
| Part 1 Placebo SAD SC | Placebo comparator | Other: PlaceboParticipants will receive matching SC injection of placebo on Day 1. |
| Part 1 Cohort 9 SAD (Chinese Participants) | Active comparator | Biological: AZD1163Participants will receive SC injection of AZD1163 on Day 1. |
| Part 1 Placebo SAD (Chinese Participants) | Placebo comparator | Other: PlaceboParticipants will receive matching SC injection of placebo on Day 1. |
| Part 2 Cohort 1 MAD (Global) | Active comparator | Biological: AZD1163Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Cohort 2 MAD (Global) | Active comparator | Biological: AZD1163Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Placebo MAD (Global) | Placebo comparator | Other: PlaceboParticipants will receive matching SC injection of placebo on Days 1 and 15. |
| Part 2 Cohort 3 MAD (Chinese Participants) | Active comparator | Biological: AZD1163Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Cohort 4 MAD (Japanese participants) | Active comparator | Biological: AZD1163Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Placebo MAD (Chinese participants) | Placebo comparator | Other: PlaceboParticipants will receive matching SC injection of placebo on Days 1 and 15. |
| Part 2 Placebo MAD (Japanese participants) | Placebo comparator | Other: PlaceboParticipants will receive matching SC injection of placebo on Days 1 and 15. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD1163In 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. | Biological | 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) |
| PlaceboIn 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. | Other | 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) |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: From Day -1 until end of study (Day 450)
To assess the safety and tolerability of single and multiple ascending doses of AZD1163 following IV or SC administration.
6 secondary outcomes
Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Number of participants with positive anti-AZD1163 antibodies
Time frame: Part 1: Day 1, 11, 29, 113, 225, 281, 365, 450; Part 2: Day 1, 15, 29, 57, 113, 281, 365, 450
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: 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.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD1163 in people with Healthy Volunteers, run by AstraZeneca at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: From Day -1 until end of study (Day 450)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.