Healthy ParticipantsPhase 1NCT05955183
Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 in Japanese and Chinese Healthy Volunteers..
A Phase 1 study testing AZD5055 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD5055 after single and multiple doses, orally administered in healthy Japanese and Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD5055
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2023to 4 Dec 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
- For Chinese subjects only:
- Participant was born in greater China, including Hong Kong, Macau, and Taiwan.
- Participant has 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview.
- Participant did not live outside of greater China for more than 10 years at the time of the Screening Period.
- For Japanese subjects only:
- Participant was born in Japan.
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- Participant has 2 Japanese biological parents and 4 Japanese grandparents as confirmed by the interview.
- Participant did not live outside of Japan for more than 10 years at the time of the Screening Period.
- Females must have a negative pregnancy test at the Screening Visit, must not be lactating and must be of non-childbearing potential.
- Males must adhere to the contraception methods.
- Have a Body mass index between 18 and 30 kg/m2 inclusive.
Who cannot join
- History of any clinically significant disease or disorder which 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 study drug.
- Any abnormal laboratory values.
- Participants with chronic infections (eg, urinary tract infection) or who are at increased risk of infection.
- History of cancer within the last 10 years.
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- History of osteoporosis, osteomalacia, Paget's disease of the bone, thyrotoxicosis, rheumatoid arthritis, Cushing's disease, or a pathological fracture.
- History of traumatic fracture within 6 months of the Screening Visit.
- Participants will be excluded if
- In premenopausal women, men less than 50 years of age: Z-scores ≤ -2.0.
- In postmenopausal women and men aged 50 years and older: T-score ≤ -2.5.
- Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results.
- Abnormal vital signs.
- 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 AZD5055.
- 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.
- Has a body temperature of > 37.7°C.
- Untreated Tuberculosis or a positive result for the Interferon gamma release assay.
- Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody, and Human immunodeficiency virus.
- History of Gilbert's syndrome.
- History of muscle disease or rhabdomyolysis.
- Plasma donation within one-month of the Screening Visit or any blood donation/blood loss more than 500 mL.
- Positive screen for drugs of abuse (excluding cannabis) at Screening.
- Current smokers who smoke > 20 cigarettes/e-cigarettes/pipes per week.
- Use of drugs with enzyme inducing properties.
- 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.
- Excessive intake of caffeine-containing drinks or food.
- Study participation by an AstraZeneca or Clinical Unit employee directly involved in the study.
- Participants who have previously received AZD5055.
- Participants who have minor medical complaints which can interfere with the study data.
- Participants who are vegans or have medical dietary restrictions.
- Participants who cannot communicate reliably with the Investigator.
- Vulnerable participants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase-1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Oral Doses in Japanese and Chinese Healthy Volunteers.
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD5055 after single and multiple doses, orally administered in healthy Japanese and Chinese participants.
Read the detailed description
The study will be conducted in 2 parts:
- Part 1 in single ascending dose (SAD)
- Multiple dose Eligible Japanese and Chinese participants will be randomized to receive oral dose of either AZD5055 or placebo.
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 the day before investigational medicinal product (IMP) administration until at least 72 hours after IMP administration.
- A Follow-up Visit within 7 ± 1 (for Part 1) and 15 ± 1 (for Part 2) days after the last IMP dose.
For the SAD part of the study, each participant will be involved in the study for 5 to 6 weeks.
For the multiple dose part of the study, each participant will be involved in the study for 7 to 8 weeks.
- Conditions
- Healthy Participants
- Being tested
- AZD5055, Placebo
- Keywords
- Single ascending dose (SAD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5055Drug
AZD5055 will be given orally to randomized participants as per the arm they are assigned.
PlaceboDrug
Placebo will be given orally to randomized participants as per the arm they are assigned.
| Study group | Role | What they receive |
|---|---|---|
| AZD5055 | Active comparator | Participants will orally receive AZD5055. Receives: Drug: AZD5055; Drug: Placebo |
| Placebo | Placebo comparator | Participants will orally receive placebo. Receives: Drug: AZD5055; 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
The safety and the tolerability after single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.
Measured: Until Follow-up (Day 7 ± 1 for Part 1 and Day 15 ± 1 for Part 2).
Secondary outcomes (3)
Maximum serum concentration (Cmax)
The Cmax after administration of single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.
Measured: Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
The AUCinf after administration of single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.
Measured: Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
Area under plasma concentration-curve from time 0 to the last quantifiable concentration (AUClast)
AUClast after administration of single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.
Measured: Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start27 Jul 2023
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955183
- Sponsor's protocol ID
- D8960C00005
- Status last verified
- Dec 2023
- First submitted
- 13 Jul 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-1, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 Following Single and Multiple Oral Doses in Japanese and Chinese Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05955183
- Acronym / sponsor ID
- D8960C00005
- Conditions
- Healthy Participants
- Keywords
- Single ascending dose (SAD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 21 Jul 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 study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD5055 after single and multiple doses, orally administered in healthy Japanese and Chinese participants.
Detailed description
The study will be conducted in 2 parts:
- Part 1 in single ascending dose (SAD)
- Multiple dose Eligible Japanese and Chinese participants will be randomized to receive oral dose of either AZD5055 or placebo.
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 the day before investigational medicinal product (IMP) administration until at least 72 hours after IMP administration.
- A Follow-up Visit within 7 ± 1 (for Part 1) and 15 ± 1 (for Part 2) days after the last IMP dose.
For the SAD part of the study, each participant will be involved in the study for 5 to 6 weeks.
For the multiple dose part of the study, each participant will be involved in the study for 7 to 8 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD5055 | Active comparator | Drug: AZD5055, Drug: PlaceboParticipants will orally receive AZD5055. |
| Placebo | Placebo comparator | Drug: AZD5055, Drug: PlaceboParticipants will orally receive placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- For Chinese subjects only:
- For Japanese subjects only:
- Females must have a negative pregnancy test at the Screening Visit, must not be lactating and must be of non-childbearing potential.
- Males must adhere to the contraception methods.
- Have a Body mass index between 18 and 30 kg/m2 inclusive.
Key exclusion criteria (33 listed)
- History of any clinically significant disease or disorder which 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 study drug.
- Any abnormal laboratory values.
- Participants with chronic infections (eg, urinary tract infection) or who are at increased risk of infection.
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 |
|---|---|---|
| AZD5055AZD5055 will be given orally to randomized participants as per the arm they are assigned. | Drug | AZD5055, Placebo |
| PlaceboPlacebo will be given orally to randomized participants as per the arm they are assigned. | Drug | AZD5055, Placebo |
Primary outcome
Number of participants with adverse events
Time frame: Until Follow-up (Day 7 ± 1 for Part 1 and Day 15 ± 1 for Part 2).
The safety and the tolerability after single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.
3 secondary outcomes
Maximum serum concentration (Cmax)
Time frame: Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
Area under plasma concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)
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 8 Dec 2023.
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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 AZD5055 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 11 inclusion and 33 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 8 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 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: Until Follow-up (Day 7 ± 1 for Part 1 and Day 15 ± 1 for Part 2).). 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 8 Dec 2023.