A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants

NCT05143905 | Completed Phase 1 FDA Drug

• 1 other identifier: D9230C00001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate safety, tolerability and pharmacokinetics (PK) of AZD7503, following subcutaneous (SC) administration of single ascending doses of AZD7503 in healthy participants.

Conditions

Safety; Tolerability; Pharmacokinetics; Healthy Participants

Keywords

First-in-Human; Placebo-controlled; AZD7503; Single Ascending Dose; Sentinel Dosing

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events (AEs)

  To assess adverse events as a variable of safety and tolerability of AZD7503 following SC single dose administration.

  Up to Final Follow-up (FU) Visit (Week 10) or Early Termination (ET) (assessed up to 14 Weeks)

Secondary Outcomes (14)

• Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD7503

  (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)

• Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD7503

  (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)

• Maximum observed plasma (peak) drug concentration (Cmax) of AZD7503

  (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)

• Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD7503

  (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)

• Time of last observed (quantifiable) concentration (tlast) of AZD7503

  (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)

Study Arms (12)

Cohort 1: AZD7503 dose 1

EXPERIMENTAL

Randomised healthy participants will receive a single dose 1 of AZD7503.

Drug: AZD7503

Cohort 2: AZD7503 dose 2

EXPERIMENTAL

Randomised healthy participants will receive a single dose 2 of AZD7503.

Drug: AZD7503

Cohort 3: AZD7503 dose 3

EXPERIMENTAL

Randomised healthy participants will receive a single dose 3 of AZD7503.

Drug: AZD7503

Cohort 4: AZD7503 dose 4

EXPERIMENTAL

Randomised healthy participants will receive a single dose 4 of AZD7503.

Drug: AZD7503

Cohort 5 : AZD7503 dose X

EXPERIMENTAL

Randomised healthy participants will receive a single dose X of AZD7503.

Drug: AZD7503

Cohort 6: AZD7503 dose Y

EXPERIMENTAL

Randomised healthy participants will receive a single dose Y of AZD7503.

Drug: AZD7503

Pooled Placebo for AZD7503 (Cohorts 1 to 6)

PLACEBO COMPARATOR

Randomised healthy participants will receive placebo.

Drug: Placebo

Japanese Cohort 1: AZD7503 dose 3

EXPERIMENTAL

Randomised healthy Japanese participants will receive a single dose 3 of AZD7503.

Drug: AZD7503

Japanese Cohort 2: AZD7503 dose 4

EXPERIMENTAL

Randomised healthy Japanese participants will receive a single dose 4 of AZD7503.

Drug: AZD7503

Placebo (Japanese Cohorts)

PLACEBO COMPARATOR

Randomised healthy Japanese participants will receive placebo.

Drug: Placebo

Chinese Cohort: AZD7503 dose 4

EXPERIMENTAL

Randomised healthy Chinese participants will receive a single dose 4 of AZD7503.

Drug: AZD7503

Placebo (Chinese Cohort)

PLACEBO COMPARATOR

Randomised healthy Chinese participants will receive placebo.

Drug: Placebo

Interventions

AZD7503 DRUG

Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y).

Chinese Cohort: AZD7503 dose 4; Cohort 1: AZD7503 dose 1; Cohort 2: AZD7503 dose 2; Cohort 3: AZD7503 dose 3; Cohort 4: AZD7503 dose 4; Cohort 5 : AZD7503 dose X; Cohort 6: AZD7503 dose Y; Japanese Cohort 1: AZD7503 dose 3; Japanese Cohort 2: AZD7503 dose 4

Placebo DRUG

Randomised participants will receive placebo by SC injection

Placebo (Chinese Cohort); Placebo (Japanese Cohorts); Pooled Placebo for AZD7503 (Cohorts 1 to 6)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy non smoking male and/or female (of non childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
• Females must have a negative pregnancy test at screening and on admission to the study centre, must not be lactating and must be of non childbearing potential.
• Body mass index (BMI) between 18 and 30 kg/m\^2, inclusive, and weigh at least 60 kg for healthy participants or between 18 and 32 kg/m\^2, inclusive, and weigh at least 50 kg for Japanese and Chinese participants.
• For Japanese and Chinese participants:
• A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes first-, second-and third-generation Japanese whose parents or grandparents are living in a country other than Japan.
• A Chinese participant is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes first-, second-and third-generation Chinese whose parents or grandparents are living in a country other than China.
• Willing to participate in retrospective genotyping analysis for HSD17B13.

You may not qualify if:

• History of any clinically important disease or disorder.
• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
• Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of administration of study intervention.
• Any laboratory values with the following deviations at screening and/or Day 1:
• Alanine aminotransferase \> Upper Limit of Normal (ULN)
• Aspartate aminotransferase \> ULN
• Total bilirubin \> ULN
• Creatinine \> ULN
• White blood cell count \< Lower Limit of Normal (LLN)
• Hemoglobin \< LLN
• Estimated glomerular filtration rate \< 60 mL/min/1.73 m\^2
• Platelets \>ULN and/or \<LLN.
• Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results other than those described above, including participants with platelet or bleeding disorders, known platelet dysfunction disorders.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or Human Immunodeficiency Virus.
• Confirmed coronavirus disease 2019 (COVID-19) infection during screening and/or admission by polymerase chain reaction (PCR) test.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

Related Links

• CSR Synopsis Redacted
• Results of this clinical trial are available on www.astrazenecaclinicaltrials.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This study is single blind with regard to treatment (AZD7503 or placebo). This means that the participant and the study centre staff will remain blinded during the dosing phase of the study and the randomisation code will only be available at each pre defined decision point before the Safety Review Committee meeting in order to review the data unblinded.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 3, 2021
• Study Start: December 6, 2021
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer 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 de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (1)