HealthyPhase 1NCT06995820
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
A Phase 1 study testing AZD1613 in people with Healthy, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD1613 in healthy participants, including Japanese and Chinese descent. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD1613
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to 16 Nov 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females of non-childbearing potential with suitable veins for cannulation or repeated venipuncture.
- Negative pregnancy test at screening and admission (females only).
- Females of non-childbearing potential confirmed by postmenopausal status or irreversible surgical sterilization.
- Sexually active fertile males must use contraception methods from first administration until 3 months after the last follow-up visit.
- Body mass index (BMI) between 18 and 32 kg/m² and weight at least 50 kg.
- Participants of Chinese descent (Part A2) must have both parents and four grandparents who are Chinese.
- Participants of Japanese descent (Part A3) must have both parents and four grandparents who are Japanese.
Who cannot join
- The history of any clinically important disease or disorder may either put the participant at risk due to participation in the study, influence the results, or affect the participant's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease affecting drug absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of first administration.
- Abnormal lab values at screening or admission (e.g., alanine aminotransferase (ALT) > upper limit normal (ULN), aspartate aminotransferase (AST) > ULN, bilirubin > 1.5 × ULN, estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m², hemoglobin < lower limit normal [LLN]).
- Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
- Any positive result for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCV Ab) or Human immunodeficiency virus (HIV).
Show all 21Show fewer
- Abnormal vital signs after 5 minutes supine rest at screening or admission (e.g., systolic BP < 90 mmHg or ≥ 140 mmHg, diastolic BP < 50 mmHg or ≥ 90 mmHg, heart rate < 45 or > 85 bpm).
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting 12-lead Electrocardiogram (ECG) at screening or admission (e.g., prolonged QTcF > 450 ms, shortened QTcF < 340 ms, family history of long QT syndrome).
- Smokers who smoke more than 5 cigarettes per day and cannot adhere to no smoking during residential visits.
- Known or suspected history of alcohol or drug abuse or excessive alcohol intake.
- Positive screen for drugs of abuse or alcohol at screening or admission.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- Use of prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, or intake of > 3 × daily recommended levels of vitamins and minerals during the 2 weeks prior to first administration.
- Plasma donation within one month of screening or any blood donation/blood loss > 500 mL during the 3 months prior to screening.
- Received another new chemical entity within 30 days or 5 half-lives (whichever is longest) of first administration.
- Previously received AZD1613.
- Involvement in the planning and/or conduct of the study.
- Judgment by the Investigator that the participant should not participate due to minor medical complaints or non-compliance with study procedures.
- Medical dietary restrictions or inability/unwillingness to comply with meals provided during the stay at the Clinical Unit.
- Inability to communicate reliably with the Investigator.
- Vulnerable participants (e.g., kept in detention, protected adults under guardianship).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of AZD1613 Following Single and Multiple Dose Administration in Healthy Participants
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD1613 in healthy participants, including Japanese and Chinese descent.
Read the detailed description
This is a first-in-human, randomized, single-blind, placebo-controlled, single and multiple ascending dose study in healthy participants and will be conducted at a single study center. It consists of two parts: Part A (Single Ascending Dose - SAD) and Part B (Multiple Ascending Dose - MAD).
Part A of the study is a SAD sequential group design study and will consist of Parts A1, A2, and A3. Part A1 is planned to consist of 7 cohorts, Part A2 is planned to consist of one cohort of participants of Chinese descent, and Part A3 is planned to consist of 2 cohorts of participants of Japanese descent.
Parts A1, A2, and A3 of the study will comprise of:
- A Screening Period of maximum 28 days.
- A Treatment Period during which each participant will receive a single subcutaneous (SC) or intravenous (IV) dose of either AZD1613 or placebo on Day 1.
- A Follow-up Period where participants will return to the study center for non-residential visits until Day 105.
Part B of the study will be a MAD sequential group design study. Up to 3 dose levels of AZD1613 are planned to be investigated in 3 cohorts of healthy participants.
Part B of the study will comprise of:
- A Screening Period of maximum 28 days.
- Three Treatment Periods during which participants will receive 3 single subcutaneous (SC) or intravenous (IV) doses of AZD1613 or placebo at 28-day intervals (Day 1, Day 29, and Day 57).
- A Follow-up Period where participants will return to the study center for non-residential visits until Day 161.
- Conditions
- Healthy
- Being tested
- AZD1613, Placebo
- Keywords
- Pharmacokinetics, Single ascending dose, Multiple ascending dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1613Drug
AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study.
PlaceboDrug
Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B of the study.
| Study group | Role | What they receive |
|---|---|---|
| Part A1 (SAD): AZD1613 (Dose 1) SC | Experimental | Participants will receive a single dose of AZD1613 (Dose 1) or matching placebo to AZD1613 as SC injection on Day 1. Receives: Drug: AZD1613; Drug: Placebo |
| Part A1 (SAD): AZD1613 (Dose 2) SC | Experimental | Participants will receive a single dose of AZD1613 (Dose 2) or matching placebo to AZD1613 as SC injection on Day 1. Receives: Drug: AZD1613; Drug: Placebo |
| Part A1 (SAD): AZD1613 (Dose 3) SC | Experimental | Participants will receive a single dose of AZD1613 (Dose 3) or matching placebo to AZD1613 as SC injection on Day 1. Receives: Drug: AZD1613; Drug: Placebo |
| Part A1 (SAD): AZD1613 (Dose 4) SC | Experimental | Participants will receive a single dose of AZD1613 (Dose 4) or matching placebo to AZD1613 as SC injection on Day 1. Receives: Drug: AZD1613; Drug: Placebo |
| Part A1 (SAD): AZD1613 (Dose 5) IV | Experimental | Participants will receive a single dose of AZD1613 (Dose 5) or matching placebo to AZD1613 as an IV infusion on Day 1. Receives: Drug: AZD1613; Drug: Placebo |
| Part A1 (SAD): AZD1613 (Dose 6) IV | Experimental | Participants will receive a single dose of AZD1613 (Dose 6) or matching placebo to AZD1613 as an IV infusion on Day 1. Receives: Drug: AZD1613; Drug: Placebo |
| Part A1 (SAD): AZD1613 (Dose 7) IV | Experimental | Participants will receive a single dose of AZD1613 (Dose 7) or matching placebo to AZD1613 as an IV infusion on Day 1. Receives: Drug: AZD1613; Drug: Placebo |
| Part A2 (SAD): AZD1613 (Dose 8) IV (Chinese) | Experimental | Chinese participants will receive a single dose of AZD1613 (Dose 8) or matching placebo to AZD1613 as an IV infusion on Day 1. Receives: Drug: AZD1613; Drug: Placebo |
| Part A3 (SAD): AZD1613 (Dose 9) SC or IV (Japanese) | Experimental | Japanese participants will receive a single dose of AZD1613 (Dose 9) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1. Receives: Drug: AZD1613; Drug: Placebo |
| Part A3 (SAD): AZD1613 (Dose 10) SC or IV (Japanese) | Experimental | Japanese participants will receive a single dose of AZD1613 (Dose 10) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1. Receives: Drug: AZD1613; Drug: Placebo |
| Part B (MAD): AZD1613 (Dose 11) SC or IV | Experimental | Participants will receive multiple doses of AZD1613 (Dose 11) or matching placebo to AZD1613 as SC injection or IV infusion on Days 1, 29 and 57. Receives: Drug: AZD1613; Drug: Placebo |
| Part B (MAD): AZD1613 (Dose 12) IV | Experimental | Participants will receive multiple doses of AZD1613 (Dose 12) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57. Receives: Drug: AZD1613; Drug: Placebo |
| Part B (MAD): AZD1613 (Dose 13) IV | Experimental | Participants will receive multiple doses of AZD1613 (Dose 13) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57. Receives: Drug: AZD1613; Drug: 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) and serious AEs.
To assess the safety and tolerability of AZD1613 following SC and/or IV administration of single and multiple ascending doses.
Measured: AEs: Part A: From Day 1 to Final Follow-up (Day 105); Part B: From Day 1 to Final Follow-up (Day 161); SAEs: Part A: From Screening (Day -28 to Day -2) to Final Follow-up visit (Day 105) Part B: From Screening (Day -28) to Final Follow-up visit (Day 161)
Secondary outcomes (5)
Area under concentration-time curve from time 0 to infinity (AUCinf) (Day 1 only)
To characterize the single and multiple dose PK of AZD1613 following SC and/or IV administration.
Measured: Part A: From Day 1 (pre-dose) to Day 105; Part B: From Day 1 (pre-dose) to Day 141
Area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the single and multiple dose PK of AZD1613 following SC and/or IV administration.
Measured: Part A: From Day 1 (pre-dose) to Day 105; Part B: From Day 1 (pre-dose) to Day 141
Maximum observed drug concentration (Cmax)
To characterize the single and multiple dose PK of AZD1613 following SC and/or IV administration.
Measured: Part A: From Day 1 (pre-dose) to Day 105; Part B: From Day 1 (pre-dose) to Day 141
Incidence of positive anti-drug antibodies (ADAs) against AZD1613 in serum
To evaluate the immunogenecity of AZD1613.
Measured: Part A: Day 1 (pre-dose), Day 29, Day 57 and Day 105; Part B: Day 1 (pre-dose), Day 29 (pre-dose), Day 57 (pre-dose), Day 85 and Day 161
Change from baseline in study-specific biomarker ABC
To evaluate target engagement by assessing change in plasma biomarker.
Measured: Part A: From Day 1 to Day 105; Part B: From Day -1 to Day 161
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start6 Jun 2025
- Primary completion16 Nov 2026 (estimated)
- Study completion16 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 72 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
- NCT06995820
- Sponsor's protocol ID
- D9050C00001
- Status last verified
- Sep 2026
- First submitted
- 28 May 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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.