Chronic Graft-versus-Host Disease (cGVHD)Phase 1NCT05885451
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants
A Phase 1 study testing AMG 592 in people with Chronic Graft-versus-Host Disease (cGVHD), run by Amgen at 1 site in Australia.
Trial summary
The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Graft-versus-Host Disease (cGVHD)
- What is being tested?
- AMG 592
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Jan 2019to 11 Apr 2019
- 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
- Participant must be first generation Japanese (4 grandparents, biologic parents, and subject born in Japan and of Japanese heritage)
- Male and female participants must be ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 25.0 kg/m^2 at the time of screening
Who cannot join
- Participant with history of prior malignancy within the last 5 years except malignancy (in situ) fully excised or treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician, non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
- Participants with a known history of autoimmune disease
- Participants who have donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP
- Participants with any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1
- Positive for Hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
- Participant has positive test results for Human Immunodeficiency Virus (HIV)
- Participant has a positive test for tuberculosis during screening defined as either a positive purified derivative (PPD) (>= 5 mm of induration at 48 to 72 hours after test is placed) OR a positive QuantiFERON test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double Blind, Placebo-controlled, Randomized, Parallel, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 Administered Subcutaneously in Healthy Japanese Subjects
The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants.
- Being tested
- AMG 592, Placebo
- Keywords
- Chronic Graft-versus-Host Disease, AMG 592, Inflammatory Conditions
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 592Drug
Administered as SC injection
PlaceboOther
Administered as SC injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: AMG 592 Dose 1 | Experimental | Participants will receive AMG 592 dose 1 subcutaneously Receives: Drug: AMG 592 |
| Arm 2: AMG 592 Dose 2 | Experimental | Participants will receive AMG 592 dose 2 subcutaneously Receives: Drug: AMG 592 |
| Arm 3: Placebo | Placebo comparator | Participants will receive placebo subcutaneously Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax) of AMG 592
Measured: Up to Day 43
Time of Maximum Observed Concentration (tmax) of AMG 592
Measured: Up to Day 43
Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592
Measured: Up to Day 43
Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)
Measured: Up to Day 43
Secondary outcomes (2)
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 to Day 43
Number of Participants who Experience Anti-AMG 592 Antibodies Formation
Measured: Up to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start29 Jan 2019
- Primary completion11 Apr 2019
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft-versus-Host Disease (cGVHD)Studies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885451
- Sponsor's protocol ID
- 20180132
- Status last verified
- Apr 2023
- First submitted
- 23 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double Blind, Placebo-controlled, Randomized, Parallel, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 Administered Subcutaneously in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT05885451
- Acronym / sponsor ID
- 20180132
- Keywords
- Chronic Graft-versus-Host Disease, AMG 592, Inflammatory Conditions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 2 Jun 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.
The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: AMG 592 Dose 1 | Experimental | Drug: AMG 592Participants will receive AMG 592 dose 1 subcutaneously |
| Arm 2: AMG 592 Dose 2 | Experimental | Drug: AMG 592Participants will receive AMG 592 dose 2 subcutaneously |
| Arm 3: Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebo subcutaneously |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participant must be first generation Japanese (4 grandparents, biologic parents, and subject born in Japan and of Japanese heritage)
- Male and female participants must be ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 25.0 kg/m^2 at the time of screening
Key exclusion criteria (7 listed)
- Participant with history of prior malignancy within the last 5 years except malignancy (in situ) fully excised or treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician, non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
- Participants with a known history of autoimmune disease
- Participants who have donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP
- Participants with any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1
- Positive for Hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
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 |
|---|---|---|
| AMG 592Administered as SC injection | Drug | Arm 1: AMG 592 Dose 1, Arm 2: AMG 592 Dose 2 |
| PlaceboAdministered as SC injection | Other | Arm 3: Placebo |
Primary outcome
Maximum Observed Serum Concentration (Cmax) of AMG 592
Time frame: Up to Day 43
Time of Maximum Observed Concentration (tmax) of AMG 592
Time frame: Up to Day 43
Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592
Time frame: Up to Day 43
Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)
Time frame: Up to Day 43
2 secondary outcomes
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 43
Number of Participants who Experience Anti-AMG 592 Antibodies Formation
Time frame: Up to Day 43
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 2 Jun 2023.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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.
MD study director
Amgen
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 AMG 592 in people with Chronic Graft-versus-Host Disease (cGVHD), run by Amgen at 1 site in Australia.
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 2 inclusion and 7 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 2 Jun 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 Australia. 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?
Maximum Observed Serum Concentration (Cmax) of AMG 592 (time frame: Up to Day 43). The study lists 4 primary outcomes in all. 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 2 Jun 2023.