Non-alcoholic SteatohepatitisPhase 1NCT05848440
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD9550 Following Single Ascending Dose Administration to Healthy Participants
A Phase 1 study testing AZD9550 in people with Non-alcoholic Steatohepatitis, run by AstraZeneca at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- What is being tested?
- AZD9550
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2023to 13 Nov 2023
- 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
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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 clinically important abnormalities in clinical chemistry, haematology or urinalysis results other than those described under exclusion criterion number 4, as judged by the Investigator.
- 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.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest.
- Note: participants consented and screened, but not randomised in this study or a previous Phase I study, are not excluded.
- Judgment by the Investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the Screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
- Participants with a medical history of Medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome (MEN 2), or a baseline serum calcitonin at or above 50 ng/L.
- Any condition that would have interfered with the evaluation of the IMP or interpretation of participant safety or study results.
- Participants who are unable to consume in full the MMTT (Mixed meal tolerance test - Ensure Plus 200 mL).
- Participants with a medical history of MTC (Medullary thyroid carcinoma) or MEN 2 (multiple endocrine neoplasia syndrome), or a baseline serum calcitonin at or above 50 ng/L.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
This study will be a Phase I, First-In-Human (FIH), randomised, single-blind, placebo-controlled, single ascending dose (SAD), sequential group study in healthy male and female participants of non- childbearing potential performed at a single study centre.
The study consists of 3 parts:
- Part A: SAD (up to 5 dose levels) of AZD9550 administered subcutaneous (SC) in healthy participants.
- Part B: 1 dose level of AZD9550 administered SC in healthy participants of Japanese descent.
- Part C: 1 dose level of AZD9550 administered intravenous (IV) in healthy participants.
The study will comprise of:
- A Screening Period of maximum 28 days.
- A Treatment Period during which participants will be resident at the Clinical Unit from 2 days before (Day -2) investigational medicinal product (IMP]) administration (Day 1) until at least 7 days (168 hours; Day 8) after IMP administration.
- Weekly out-clinic visits on Days 15, 22, 29, and 36.
- A Follow-up Visit 6 weeks (Day 43) after the IMP dose.
- Conditions
- Non-alcoholic Steatohepatitis
- Being tested
- AZD9550, Placebo
- Keywords
- Non-alcoholic steatohepatitis (NASH), Liver disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9550Drug
Participants will be administered AZD9550 subcutaneously.
AZD9550Drug
Participants will be administered AZD9550 intravenously.
PlaceboDrug
Participants will be administered matching volumes of placebo subcutaneously or intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Participants will be administered single ascending SC doses of AZD9550 or a placebo. Receives: Drug: AZD9550; Drug: Placebo |
| Part B | Experimental | Participants will be administered one SC dose of AZD9550 or a placebo. Receives: Drug: AZD9550; Drug: Placebo |
| Part C | Experimental | Participants will be administered one IV dose of AZD9550 or a placebo. Receives: Drug: AZD9550; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the study (up to 6 months)
Secondary outcomes (4)
Area under concentration time curve from time 0 to infinity (AUCinf)
The AUCinf 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.
Measured: Day 1 until Day 43 (follow-up visit)
Area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
The AUClast 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.
Measured: Day 1 until Day 43 (follow-up visit)
Maximum observed concentration (Cmax)
The Cmax 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.
Measured: Day 1 until Day 43 (follow-up visit)
Incidence of Anti-Drug Antibodies (ADAs)
The immunogenicity of AZD9550 following SC and/or IV administration of AZD9550 will be assessed.
Measured: Day 1 until Day 43 (follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start2 May 2023
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic SteatohepatitisStudies 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
- Model description
- Placebo-control
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT05848440
- Sponsor's protocol ID
- D8460C00001
- Other IDs
- 2022-003308-34
- Status last verified
- Dec 2023
- First submitted
- 31 Mar 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05848440
- Acronym / sponsor ID
- D8460C00001
- Conditions
- Non-alcoholic Steatohepatitis
- Keywords
- Non-alcoholic steatohepatitis (NASH), Liver disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 2 May 2023 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 8 May 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.
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.
Detailed description
This study will be a Phase I, First-In-Human (FIH), randomised, single-blind, placebo-controlled, single ascending dose (SAD), sequential group study in healthy male and female participants of non- childbearing potential performed at a single study centre.
The study consists of 3 parts:
- Part A: SAD (up to 5 dose levels) of AZD9550 administered subcutaneous (SC) in healthy participants.
- Part B: 1 dose level of AZD9550 administered SC in healthy participants of Japanese descent.
- Part C: 1 dose level of AZD9550 administered intravenous (IV) in healthy participants.
The study will comprise of:
- A Screening Period of maximum 28 days.
- A Treatment Period during which participants will be resident at the Clinical Unit from 2 days before (Day -2) investigational medicinal product (IMP]) administration (Day 1) until at least 7 days (168 hours; Day 8) after IMP administration.
- Weekly out-clinic visits on Days 15, 22, 29, and 36.
- A Follow-up Visit 6 weeks (Day 43) after the IMP dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Placebo-control
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: AZD9550, Drug: PlaceboParticipants will be administered single ascending SC doses of AZD9550 or a placebo. |
| Part B | Experimental | Drug: AZD9550, Drug: PlaceboParticipants will be administered one SC dose of AZD9550 or a placebo. |
| Part C | Experimental | Drug: AZD9550, Drug: PlaceboParticipants will be administered one IV dose of AZD9550 or a placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (23 listed)
- 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:
- Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results other than those described under exclusion criterion number 4, as judged by the Investigator.
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 |
|---|---|---|
| AZD9550Participants will be administered AZD9550 subcutaneously. | Drug | Part A, Part B |
| AZD9550Participants will be administered AZD9550 intravenously. | Drug | Part C |
| PlaceboParticipants will be administered matching volumes of placebo subcutaneously or intravenously. | Drug | Part A, Part B, Part C |
Primary outcome
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Throughout the study (up to 6 months)
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.
4 secondary outcomes
Area under concentration time curve from time 0 to infinity (AUCinf)
Time frame: Day 1 until Day 43 (follow-up visit)
Area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1 until Day 43 (follow-up visit)
Maximum observed concentration (Cmax)
Time frame: Day 1 until Day 43 (follow-up visit)
Incidence of Anti-Drug Antibodies (ADAs)
Time frame: Day 1 until Day 43 (follow-up visit)
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 11 Dec 2023.
- 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.
Related trials for Non-alcoholic Steatohepatitis
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD9550 in people with Non-alcoholic Steatohepatitis, run by AstraZeneca at 1 site in United Kingdom.
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 6 inclusion and 23 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Throughout the study (up to 6 months)). 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 11 Dec 2023.