Chronic Graft-versus-host Disease (cGVHD)Phase 1NCT05873907
A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants
A Phase 1 study testing AMG 592 in people with Chronic Graft-versus-host Disease (cGVHD), run by Amgen at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the safety, tolerability and immunogenicity profile of single and multiple dose administrations of AMG 592 in 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
- 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
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2015to 28 Jul 2017
- 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
- Males must agree to practice an acceptable method of effective birth control while on study through 2 weeks after receiving the dose of study drug.
- Males must be willing to abstain from sperm donation while on study through 2 weeks after receiving the (last [multiple dose studies]) dose of study drug.
- Male and female subjects ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m^2 at the time of screening.
- Females must be of non-reproductive potential (ie, postmenopausal - age ≥ 55 years with cessation of menses for 12 months or more, or according to the definition of "postmenopausal range" for the laboratory involved OR history of hysterectomy; OR history of bilateral oophorectomy).
Who cannot join
- Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B) or detectable Hepatitis C virus Ribonucleic acid (RNA) by Polymerase Chain Reaction (PCR) (indicative of active Hepatitis C - screening is generally done by Hepatitis C Antibody (HepCAb), followed by Hepatitis C virus RNA by PCR if HepCAb is positive).
- Positive results for Human Immunodeficiency Virus (HIV).
- Participant has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or participant has a positive purified protein derivative (PPD) or QuantiFERON or T-Spot test at Screening. Participants with a documented negative PPD or QuantiFERON or T-Spot test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.
- Currently receiving treatment in another investigational device or drug study, or less than 30 days or less than 5 half-lives, whichever is longer, since ending treatment on another investigational device or drug study.
- Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
- Any active infection for which systemic anti-infectives were used within 4 weeks prior to Day 1.
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- Females who are lactating/breastfeeding or who plan to breastfeed while on study through 2 weeks after receiving the dose of study drug.
- Female participants with a positive pregnancy test.
- Males with partners who are pregnant or planning to become pregnant while the participant is on study through 2 weeks after receiving the dose of study drug.
- Has any significant abnormality during the screening physical examination, electrocardiogram (ECG), or laboratory evaluation that in the opinion of the Investigator, in consultation with the Amgen Medical Monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Unwilling or unable to abstain from alcohol consumption within 48 hours prior to each visit (including Screening).
- Is a current smoker, has used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months from Screening, and cumulative smoking history is ≥ 10 pack years.
- Unwilling or unable to refrain from strenuous exercise (eg, heavy lifting, weight training, and aerobics) for 72 hours prior to each visit that includes blood collection.
- Has donated or lost ≥ 500 mL of blood or plasma within 8 weeks of administration of the first dose of IP.
- Participants with a known history of autoimmune disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Subjects
The primary objective of this study is to evaluate the safety, tolerability and immunogenicity profile of single and multiple dose administrations of AMG 592 in healthy 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 |
|---|---|---|
| AMG 592: Dose 1 | Experimental | Administered as a single dose subcutaneous (SC) injection. Receives: Drug: AMG 592 |
| AMG 592: Dose 2 | Experimental | Administered as a single dose SC injection. Receives: Drug: AMG 592 |
| AMG 592: Dose 3 | Experimental | Administered as a single dose SC injection. Receives: Drug: AMG 592 |
| AMG 592: Dose 4 | Experimental | Administered as a single dose SC injection. Receives: Drug: AMG 592 |
| AMG 592: Dose 5 | Experimental | Administered as a single dose SC injection. Receives: Drug: AMG 592 |
| AMG 592: Dose 6 | Experimental | Administered as a single dose SC injection. Receives: Drug: AMG 592 |
| AMG 592: Dose 7 | Experimental | Administered as a single dose SC injection. Receives: Drug: AMG 592 |
| AMG 592: Dose 8 | Experimental | Administered as a single dose SC injection. Receives: Drug: AMG 592 |
| Placebo | Placebo comparator | Administered as SC injection. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs will be recorded as TEAEs.
Measured: Day 1 up to Day 57
Number of Participants with Anti-AMG 592 Antibodies
Measured: Day 1 up to Day 57
Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs)
Measured: One week after AMG 592 administration (up to 7 days)
Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons)
Measured: One week after AMG 592 administration (up to 7 days)
Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs)
Measured: One week after AMG 592 administration (up to 7 days)
Secondary outcomes (3)
Maximum Observed Serum Concentration (Cmax) of AMG 592
Measured: Day 1 up to Day 57
Time of Maximum Observed Concentration (tmax) of AMG 592
Measured: Day 1 up to Day 57
Area Under the Concentration-time Curve (AUC) of AMG 592
Measured: Day 1 up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start19 Oct 2015
- Primary completion16 Jun 2017
- Study completion28 Jul 2017
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
- 64 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
- NCT05873907
- Sponsor's protocol ID
- 20140324
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 24 May 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 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05873907
- Acronym / sponsor ID
- 20140324
- Keywords
- Chronic Graft-versus-Host Disease, AMG 592, Inflammatory Conditions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2015 (actual)
- Primary completion
- 16 Jun 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 24 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.
The primary objective of this study is to evaluate the safety, tolerability and immunogenicity profile of single and multiple dose administrations of AMG 592 in healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| AMG 592: Dose 1 | Experimental | Drug: AMG 592Administered as a single dose subcutaneous (SC) injection. |
| AMG 592: Dose 2 | Experimental | Drug: AMG 592Administered as a single dose SC injection. |
| AMG 592: Dose 3 | Experimental | Drug: AMG 592Administered as a single dose SC injection. |
| AMG 592: Dose 4 | Experimental | Drug: AMG 592Administered as a single dose SC injection. |
| AMG 592: Dose 5 | Experimental | Drug: AMG 592Administered as a single dose SC injection. |
| AMG 592: Dose 6 | Experimental | Drug: AMG 592Administered as a single dose SC injection. |
| AMG 592: Dose 7 | Experimental | Drug: AMG 592Administered as a single dose SC injection. |
| AMG 592: Dose 8 | Experimental | Drug: AMG 592Administered as a single dose SC injection. |
| Placebo | Placebo comparator | Other: PlaceboAdministered as SC injection. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males must agree to practice an acceptable method of effective birth control while on study through 2 weeks after receiving the dose of study drug.
- Males must be willing to abstain from sperm donation while on study through 2 weeks after receiving the (last [multiple dose studies]) dose of study drug.
- Male and female subjects ≥ 18 and ≤ 55 years of age with a body mass index (BMI) of ≥ 18.0 and ≤ 32.0 kg/m^2 at the time of screening.
- Females must be of non-reproductive potential (ie, postmenopausal - age ≥ 55 years with cessation of menses for 12 months or more, or according to the definition of "postmenopausal range" for the laboratory involved OR history of hysterectomy; OR history of bilateral oophorectomy).
Key exclusion criteria (15 listed)
- Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B) or detectable Hepatitis C virus Ribonucleic acid (RNA) by Polymerase Chain Reaction (PCR) (indicative of active Hepatitis C - screening is generally done by Hepatitis C Antibody (HepCAb), followed by Hepatitis C virus RNA by PCR if HepCAb is positive).
- Positive results for Human Immunodeficiency Virus (HIV).
- Participant has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or participant has a positive purified protein derivative (PPD) or QuantiFERON or T-Spot test at Screening. Participants with a documented negative PPD or QuantiFERON or T-Spot test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening.
- Currently receiving treatment in another investigational device or drug study, or less than 30 days or less than 5 half-lives, whichever is longer, since ending treatment on another investigational device or drug study.
- Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
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 | AMG 592: Dose 1, AMG 592: Dose 2, AMG 592: Dose 3, AMG 592: Dose 4, AMG 592: Dose 5, AMG 592: Dose 6, AMG 592: Dose 7, AMG 592: Dose 8 |
| PlaceboAdministered as SC injection | Other | Placebo |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 57
Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs will be recorded as TEAEs.
Number of Participants with Anti-AMG 592 Antibodies
Time frame: Day 1 up to Day 57
Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs)
Time frame: One week after AMG 592 administration (up to 7 days)
Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons)
Time frame: One week after AMG 592 administration (up to 7 days)
Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs)
Time frame: One week after AMG 592 administration (up to 7 days)
3 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of AMG 592
Time frame: Day 1 up to Day 57
Time of Maximum Observed Concentration (tmax) of AMG 592
Time frame: Day 1 up to Day 57
Area Under the Concentration-time Curve (AUC) of AMG 592
Time frame: Day 1 up to Day 57
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 24 May 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 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 15 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 24 May 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 Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 up to Day 57). The study lists 5 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 24 May 2023.