Healthy ParticipantsPhase 1NCT04994106

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5462 Following Single and Multiple Ascending Dose Administration to Healthy Volunteers

A Phase 1 study testing AZD5462 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study will assess the safety, tolerability, and pharmacokinetic (PK) of AZD5462 following single ascending dose (SAD) and multiple ascending dose (MAD) administration in healthy male and female participants and healthy participants of Japanese 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 Participants
What is being tested?: AZD5462
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 98 participants
Where: 1 siteUnited States
Study dates: 27 Jul 2021to 20 Sep 2022
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female (of non-childbearing potential) participants aged 18 to 50 years of age and healthy participants of Japanese descent, 20 to 50 years of age, with suitable veins for cannulation or repeated venipuncture
Females must have a negative pregnancy test at the Screening Visit
Have a body mass index between 18 and 32 kg/m^2 inclusive and weigh at least 50 kg and no more than 105 kg inclusive
For cohorts comprised solely of participants of Japanese descent, a participant will be considered of Japanese descent only if both parents and all grandparents are Japanese

Who cannot join

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 the first administration of study drug
Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results
Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody, and Human immunodeficiency virus
Abnormal vital signs

Show all 11Show fewer

Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG
History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5462
Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of study drug
Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days (or 5 half-lives, whichever is the longest) of the first administration of study drug in this study
Clinical signs and symptoms consistent with Coronavirus disease 2019, eg, fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening or on admission

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5462 Following Single and Multiple Ascending Dose Administration to Healthy Volunteers

Read the detailed description

This Phase I, First in Human (FIH), randomized single-blind, placebo-controlled study will consist of 2 parts (Part A and Part B) with an interleaved study design.

Part A of the study will be a sequential SAD design with 5 dose levels planned to be investigated across 8 cohorts, of which 3 cohorts will solely comprise of participants of Japanese descent. Within each cohort, 6 participants will be randomized to receive AZD5462 and 2 participants randomized to receive placebo.

Part B of the study will be a sequential MAD design with 4 dose levels of AZD5462 planned to be investigated across 5 cohorts, of which 1 cohort will comprise solely of participants of Japanese descent. Within each cohort 6 participants will be randomized to receive AZD5462 and 2 participants randomized to receive placebo.

The duration for participants randomized to Part A of the study is 5 to 6 weeks, and for Part B, 6 to 7 weeks.

Conditions: Healthy Participants
Being tested: AZD5462, Placebo
Keywords: Healthy participants of Japanese descent, First-in-Human, 2-part study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD5462Drug
Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively.
PlaceboDrug
Participants will receive Placebo matched to AZD5462.

Study groups in NCT04994106
Study group	Role	What they receive
Cohort A1: AZD5462 Dose 1	Experimental	Randomized healthy participants will receive Dose 1 of AZD5462. Receives: Drug: AZD5462
Cohort A2: AZD5462 Dose 2	Experimental	Randomized healthy participants will receive Dose 2 of AZD5462. Receives: Drug: AZD5462
Cohort A3: AZD5462 Dose 3	Experimental	Randomized healthy participants will receive Dose 3 of AZD5462. Receives: Drug: AZD5462
Cohort A4 Japanese descent: AZD5462 Dose 3	Experimental	Randomized participants of Japanese descent will receive Dose 3 of AZD5462. Receives: Drug: AZD5462
Cohort A5: AZD5462 Dose 4	Experimental	Randomized healthy participants will receive Dose 4 of AZD5462. Receives: Drug: AZD5462
Cohort A6 Japanese descent: AZD5462 Dose 4	Experimental	Randomized participants of Japanese descent will receive Dose 4 of AZD5462. Receives: Drug: AZD5462
Cohort A7: AZD5462 Dose 5	Experimental	Randomized healthy participants will receive Dose 5 of AZD5462. Receives: Drug: AZD5462
Cohort A8 Japanese descent: AZD5462 Dose 5	Experimental	Randomized participants of Japanese descent will receive Dose 5 of AZD5462. Receives: Drug: AZD5462
Part A: Placebo (Healthy Participants)	Placebo comparator	Randomized healthy participants will receive Placebo matched to AZD5462. Receives: Drug: Placebo
Part A: Placebo (Japanese descent participants)	Placebo comparator	Randomized participants of Japanese descent will receive Placebo matched to AZD5462. Receives: Drug: Placebo
Cohort B1: AZD5462 Dose 1	Experimental	Randomized healthy participants will receive Dose 1 of AZD5462. Receives: Drug: AZD5462
Cohort B2: AZD5462 Dose 2	Experimental	Randomized healthy participants will receive Dose 2 of AZD5462. Receives: Drug: AZD5462
Cohort B3: AZD5462 Dose 3	Experimental	Randomized healthy participants will receive Dose 3 of AZD5462. Receives: Drug: AZD5462
Cohort B4: AZD5462 Dose 4	Experimental	Randomized healthy participants will receive Dose 4 of AZD5462. Receives: Drug: AZD5462
Cohort B5 Japanese descent: AZD5462 Dose 4	Experimental	Randomized participants of Japanese descent will receive Dose 4 of AZD5462. Receives: Drug: AZD5462
Part B: Placebo (Healthy participants)	Placebo comparator	Randomized healthy participants will receive Placebo matched to AZD5462. Receives: Drug: Placebo
Part B: Placebo (Japanese descent participants)	Placebo comparator	Randomized participants of Japanese descent will receive Placebo matched to AZD5462. Receives: 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
Assessment of the safety and tolerability of AZD5462 following administration of single ascending doses (Part A) and multiple ascending doses (Part B).
Measured: Upto Follow-up (Part A: Day 10 ± 3; Part B: Day 19 ± 3)

Secondary outcomes (4)

Maximum observed plasma (peak) drug concentration (Cmax) for AZD5462
Characterization of the single dose and steady state PK of AZD5462 following administration.
Measured: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) for AZD5462
Characterization of the single dose and steady state PK of AZD5462 following administration.
Measured: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)
Area under plasma concentration time curve from zero to infinity (AUCinf) for AZD5462
Characterization of the single dose and steady state PK of AZD5462 following administration.
Measured: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)
Renal clearance of drug from plasma (CLR) for AZD5462
Characterization of the single dose and steady state PK of AZD5462 following administration.
Measured: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 202120 Sep 2022

First posted6 Aug 2021
Study start27 Jul 2021
Primary completion20 Sep 2022
Study completion20 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies 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: Other
Allocation: Randomised
Intervention model: Sequential
Model description: This is randomized single-blind, and placebo-controlled study
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04994106
Sponsor's protocol ID: D9090C00001
Status last verified: Oct 2022
First submitted: 29 Jul 2021
Last updated: 5 Oct 2022
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. 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 shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Participants trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5462 Following Single and Multiple Ascending Dose Administration to Healthy Volunteers
ClinicalTrials.gov ID: NCT04994106
Acronym / sponsor ID: D9090C00001
Conditions: Healthy Participants
Keywords: Healthy participants of Japanese descent, First-in-Human, 2-part study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 27 Jul 2021 (actual)
Primary completion: 20 Sep 2022 (actual)
Study completion: 20 Sep 2022 (actual)
First posted: 6 Aug 2021 (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.

Detailed description

This Phase I, First in Human (FIH), randomized single-blind, placebo-controlled study will consist of 2 parts (Part A and Part B) with an interleaved study design.

The duration for participants randomized to Part A of the study is 5 to 6 weeks, and for Part B, 6 to 7 weeks.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 17
Model description: This is randomized single-blind, and placebo-controlled study

Arm	Type	Receives
Cohort A1: AZD5462 Dose 1	Experimental	Drug: AZD5462Randomized healthy participants will receive Dose 1 of AZD5462.
Cohort A2: AZD5462 Dose 2	Experimental	Drug: AZD5462Randomized healthy participants will receive Dose 2 of AZD5462.
Cohort A3: AZD5462 Dose 3	Experimental	Drug: AZD5462Randomized healthy participants will receive Dose 3 of AZD5462.
Cohort A4 Japanese descent: AZD5462 Dose 3	Experimental	Drug: AZD5462Randomized participants of Japanese descent will receive Dose 3 of AZD5462.
Cohort A5: AZD5462 Dose 4	Experimental	Drug: AZD5462Randomized healthy participants will receive Dose 4 of AZD5462.
Cohort A6 Japanese descent: AZD5462 Dose 4	Experimental	Drug: AZD5462Randomized participants of Japanese descent will receive Dose 4 of AZD5462.
Cohort A7: AZD5462 Dose 5	Experimental	Drug: AZD5462Randomized healthy participants will receive Dose 5 of AZD5462.
Cohort A8 Japanese descent: AZD5462 Dose 5	Experimental	Drug: AZD5462Randomized participants of Japanese descent will receive Dose 5 of AZD5462.
Part A: Placebo (Healthy Participants)	Placebo comparator	Drug: PlaceboRandomized healthy participants will receive Placebo matched to AZD5462.
Part A: Placebo (Japanese descent participants)	Placebo comparator	Drug: PlaceboRandomized participants of Japanese descent will receive Placebo matched to AZD5462.
Cohort B1: AZD5462 Dose 1	Experimental	Drug: AZD5462Randomized healthy participants will receive Dose 1 of AZD5462.
Cohort B2: AZD5462 Dose 2	Experimental	Drug: AZD5462Randomized healthy participants will receive Dose 2 of AZD5462.
Cohort B3: AZD5462 Dose 3	Experimental	Drug: AZD5462Randomized healthy participants will receive Dose 3 of AZD5462.
Cohort B4: AZD5462 Dose 4	Experimental	Drug: AZD5462Randomized healthy participants will receive Dose 4 of AZD5462.
Cohort B5 Japanese descent: AZD5462 Dose 4	Experimental	Drug: AZD5462Randomized participants of Japanese descent will receive Dose 4 of AZD5462.
Part B: Placebo (Healthy participants)	Placebo comparator	Drug: PlaceboRandomized healthy participants will receive Placebo matched to AZD5462.
Part B: Placebo (Japanese descent participants)	Placebo comparator	Drug: PlaceboRandomized participants of Japanese descent will receive Placebo matched to AZD5462.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy male and female (of non-childbearing potential) participants aged 18 to 50 years of age and healthy participants of Japanese descent, 20 to 50 years of age, with suitable veins for cannulation or repeated venipuncture
Females must have a negative pregnancy test at the Screening Visit
Have a body mass index between 18 and 32 kg/m^2 inclusive and weigh at least 50 kg and no more than 105 kg inclusive
For cohorts comprised solely of participants of Japanese descent, a participant will be considered of Japanese descent only if both parents and all grandparents are Japanese

Key exclusion criteria (11 listed)

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 the first administration of study drug
Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results
Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody, and Human immunodeficiency virus

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
AZD5462Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively.	Drug	Cohort A1: AZD5462 Dose 1, Cohort A2: AZD5462 Dose 2, Cohort A3: AZD5462 Dose 3, Cohort A4 Japanese descent: AZD5462 Dose 3, Cohort A5: AZD5462 Dose 4, Cohort A6 Japanese descent: AZD5462 Dose 4, Cohort A7: AZD5462 Dose 5, Cohort A8 Japanese descent: AZD5462 Dose 5, Cohort B1: AZD5462 Dose 1, Cohort B2: AZD5462 Dose 2, Cohort B3: AZD5462 Dose 3, Cohort B4: AZD5462 Dose 4, Cohort B5 Japanese descent: AZD5462 Dose 4
PlaceboParticipants will receive Placebo matched to AZD5462.	Drug	Part A: Placebo (Healthy Participants), Part A: Placebo (Japanese descent participants), Part B: Placebo (Healthy participants), Part B: Placebo (Japanese descent participants)

Primary outcome

Number of Participants with Adverse Events
Time frame: Upto Follow-up (Part A: Day 10 ± 3; Part B: Day 19 ± 3)
Assessment of the safety and tolerability of AZD5462 following administration of single ascending doses (Part A) and multiple ascending doses (Part B).

4 secondary outcomes

Maximum observed plasma (peak) drug concentration (Cmax) for AZD5462
Time frame: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) for AZD5462
Time frame: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)
Area under plasma concentration time curve from zero to infinity (AUCinf) for AZD5462
Time frame: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)
Renal clearance of drug from plasma (CLR) for AZD5462
Time frame: Part A: Day 1 (pre-dose and post-dose), and Days 2, 3, and 10 (post-dose); Part B: Days 1 to 19 (pre and post-doses)

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 5 Oct 2022.
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. 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 shared.

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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 AZD5462 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.

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 11 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 5 Oct 2022. 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 States. 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 (time frame: Upto Follow-up (Part A: Day 10 ± 3; Part B: Day 19 ± 3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04994106.

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 5 Oct 2022.