A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants

NCT05848440 | Completed Phase 1

• 2 other identifiers: D8460C000012022-003308-34
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants.

Conditions

Non-alcoholic Steatohepatitis

Keywords

Non-alcoholic steatohepatitis (NASH); Liver disease

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs) and Serious Adverse Events (SAEs)

  The safety and tolerability of AZD9550 following SC administration of single ascending doses to healthy participants, SC administration of a single dose to Japanese participants, and IV administration of a single dose to healthy participants will be assessed.

  Throughout the study (up to 6 months)

Secondary Outcomes (4)

• Area under concentration time curve from time 0 to infinity (AUCinf)

  Day 1 until Day 43 (follow-up visit)

• Area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast)

  Day 1 until Day 43 (follow-up visit)

• Maximum observed concentration (Cmax)

  Day 1 until Day 43 (follow-up visit)

• Incidence of Anti-Drug Antibodies (ADAs)

  Day 1 until Day 43 (follow-up visit)

Study Arms (3)

Part A

EXPERIMENTAL

Participants will be administered single ascending SC doses of AZD9550 or a placebo.

Drug: AZD9550; Drug: Placebo

Part B

EXPERIMENTAL

Participants will be administered one SC dose of AZD9550 or a placebo.

Drug: AZD9550; Drug: Placebo

Part C

EXPERIMENTAL

Participants will be administered one IV dose of AZD9550 or a placebo.

Drug: AZD9550; Drug: Placebo

Interventions

AZD9550 DRUG

Participants will be administered AZD9550 subcutaneously.

Part A; Part B

Placebo DRUG

Participants will be administered matching volumes of placebo subcutaneously or intravenously.

Part A; Part B; Part C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study-specific procedures.
• Healthy male and female participants aged 18 to 55 years.
• Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating, and must be of non childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:
• Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and Follicle stimulating hormone (FSH) levels in the postmenopausal range.
• Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
• Have a Body mass index (BMI) between 18 and 30 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at Screening and admission.

You may not qualify if:

• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
• 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 the first administration of Investigational medicinal product (IMP).
• Any laboratory values with the following deviations at Screening and admission:
• Alanine aminotransferase \> Upper limit of normal (ULN)
• Aspartate aminotransferase \> ULN
• eGFR \< 60 mL/min/1.73m2 (to be calculated using CKD-EPI formula)
• White blood cell count \< LLN
• Hemoglobin \< LLN
• Neutrophil Count \<1.5 × 10\*9/L
• Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C antibody and Human immunodeficiency virus (HIV).
• Abnormal vital signs, after 10 minutes supine rest at Screening.
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting Electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG that may interfere with the interpretation of QTc interval changes, including abnormal ST T wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD9550.
• Plasma donation within one month of the Screening Visit or any blood donation/blood loss \> 500 mL during the 3 months prior to the Screening Visit.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant and the Clinical Unit staff will remain blinded during the dosing phase of the study.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-control

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: May 8, 2023
• Study Start: May 2, 2023
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

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

GB (1)