CardiovascularPhase 1NCT03170193

AMG 529 First in Human Study

A Phase 1 study testing AMG 529 in people with Cardiovascular, run by Amgen 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

A study to assess the safety and tolerability of AMG 529 following single, ascending doses administered subcutaneously (SC) or intravenously (IV) in healthy adults. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular
What is being tested?: AMG 529
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 States
Study dates: 15 May 2017to 17 Nov 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically relevant medical disorders
Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening
Women must be of non-reproductive potential as defined in protocol
Other inclusion criteria may apply

Who cannot join

Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives (whichever is longer), since ending treatment on another investigational device or drug study(s) prior to receiving the first dose of investigational product
Women who are lactating/breastfeeding or who plan to breastfeed while on study through 90 days after receiving the dose of investigational product
Men with partners who are pregnant or planning to become pregnant while the subject is on study through 90 days after receiving the dose of investigational product
Positive pregnancy test at screening or day -1
Other exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 529 in Healthy Subjects

A study to assess the safety and tolerability of AMG 529 following single, ascending doses administered subcutaneously (SC) or intravenously (IV) in healthy adults.

Conditions: Cardiovascular
Being tested: AMG 529, Placebo

What participants receive

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

AMG 529Drug
Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection
PlaceboDrug
Single doses of matching placebo by SC or IV injection

Study groups in NCT03170193
Study group	Role	What they receive
AMG 529	Experimental	Participants received a single dose of AMG 529 at ascending dose levels by either subcutaneous or intravenous injection. Receives: Drug: AMG 529
Placebo	Placebo comparator	Participants received a single dose of placebo matching to AMG 529 by either subcutaneous or intravenous injection. 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 (AEs)
Determination of the severity of adverse events was according to the following: grade 1 = mild (eg, asymptomatic or mild symptoms); grade 2 = moderate (eg, minimal intervention indicated or interferes with activity); grade 3 = severe (eg, medically significant but not immediately life-threatening, prevents daily activity, or requires treatment); grade 4 = life-threatening (ie, refers to an event in which the participant was, in the view of the investigator, at risk of death at the time of the event); and grade 5 = fatal.
A serious adverse event was defined as an adverse event that met at least 1 of the following criteria:
- fatal
- life threatening
- required in patient hospitalization or prolongation of existing hospitalization
- resulted in persistent or significant disability/incapacity
- congenital anomaly/birth defect
- other medically important serious event.
Measured: From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.

Secondary outcomes (8)

Maximum Observed Concentration (Cmax) of AMG 529
Measured: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.
Time to Maximum Observed Concentration (Tmax) of AMG 529
Measured: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.
Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529
Measured: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.
Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time
Measured: Baseline and days 3, 8, and 30
Change From Baseline in Total Cholesterol Concentration Over Time
Measured: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time
Measured: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time
Measured: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.
Change From Baseline in Triglycerides Concentration Over Time
Measured: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.

Timeline

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

15 May 201717 Nov 2017

First posted30 May 2017
Study start15 May 2017
Primary completion17 Nov 2017
Study completion17 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CardiovascularStudies 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: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Within each dose cohort participants were randomized in a 3:1 ratio to receive either AMG 529 or placebo.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03170193
Sponsor's protocol ID: 20160338
Status last verified: Apr 2019
First submitted: 25 May 2017
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 529 in Healthy Subjects
ClinicalTrials.gov ID: NCT03170193
Acronym / sponsor ID: 20160338
Conditions: Cardiovascular
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 15 May 2017 (actual)
Primary completion: 17 Nov 2017 (actual)
Study completion: 17 Nov 2017 (actual)
First posted: 30 May 2017 (actual)
Results: Posted 5 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A study to assess the safety and tolerability of AMG 529 following single, ascending doses administered subcutaneously (SC) or intravenously (IV) in healthy adults.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Within each dose cohort participants were randomized in a 3:1 ratio to receive either AMG 529 or placebo.

Arm	Type	Receives
AMG 529	Experimental	Drug: AMG 529Participants received a single dose of AMG 529 at ascending dose levels by either subcutaneous or intravenous injection.
Placebo	Placebo comparator	Drug: PlaceboParticipants received a single dose of placebo matching to AMG 529 by either subcutaneous or intravenous injection.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy men and women ≥ 18 to ≤ 55 years old with no history or evidence of clinically relevant medical disorders
Body mass index (BMI) between 18 and 32 kg/m², inclusive, at screening
Women must be of non-reproductive potential as defined in protocol
Other inclusion criteria may apply

Key exclusion criteria (5 listed)

Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives (whichever is longer), since ending treatment on another investigational device or drug study(s) prior to receiving the first dose of investigational product
Women who are lactating/breastfeeding or who plan to breastfeed while on study through 90 days after receiving the dose of investigational product
Men with partners who are pregnant or planning to become pregnant while the subject is on study through 90 days after receiving the dose of investigational product
Positive pregnancy test at screening or day -1
Other exclusion criteria may apply

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 529Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection	Drug	AMG 529
PlaceboSingle doses of matching placebo by SC or IV injection	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events (AEs)
Time frame: From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.
Determination of the severity of adverse events was according to the following: grade 1 = mild (eg, asymptomatic or mild symptoms); grade 2 = moderate (eg, minimal intervention indicated or interferes with activity); grade 3 = severe (eg, medically significant but not immediately life-threatening, prevents daily activity, or requires treatment); grade 4 = life-threatening (ie, refers to an event in which the participant was, in the view of the investigator, at risk of death at the time of the event); and grade 5 = fatal. A serious adverse event was defined as an adverse event that met at least 1 of the following criteria: * fatal * life threatening * required in patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.

8 secondary outcomes

Maximum Observed Concentration (Cmax) of AMG 529
Time frame: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.
Time to Maximum Observed Concentration (Tmax) of AMG 529
Time frame: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.
Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529
Time frame: Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.
Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time
Time frame: Baseline and days 3, 8, and 30
Change From Baseline in Total Cholesterol Concentration Over Time
Time frame: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.
Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time
Time frame: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time
Time frame: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.
Change From Baseline in Triglycerides Concentration Over Time
Time frame: Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.

Results and safety

Results posted to the registry on 5 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	12	11
AMG 529 21 mg SC	6	5
AMG 529 70 mg SC	6	6
AMG 529 210 mg SC	6	5
AMG 529 420 mg SC	6	6
AMG 529 700 mg SC	6	6
AMG 529 70 mg IV	6	6

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.. Count of participants. Unit: Participants

Measure	Placebo n = 12	AMG 529 210 mg SC n = 6	AMG 529 420 mg SC n = 6	AMG 529 700 mg SC n = 6	AMG 529 70 mg IV n = 6
All adverse events	3	2	2	3	2
Adverse events Grade ≥ 2	0	1	0	0	1
Adverse events Grade ≥ 3	0	0	0	0	0
Adverse events Grade ≥ 4	0	0	0	0	0
Serious adverse events	0	0	0	0	0
AEs leading to discontinuation of study drug	0	0	0	0	0
Treatment-related adverse events	1	2	2	0	2
Fatal adverse events	0	0	0	0	0

Population analysed: Randomized participants who received at least 1 dose of AMG 529 or placebo.

8 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 12 (0%)	3 of 12 (25%)	0 of 12
AMG 529 21 mg SC	0 of 6 (0%)	0 of 6 (0%)	0 of 6
AMG 529 70 mg SC	0 of 6 (0%)	0 of 6 (0%)	0 of 6
AMG 529 210 mg SC	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
AMG 529 420 mg SC	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
AMG 529 700 mg SC	0 of 6 (0%)	3 of 6 (50%)	0 of 6
AMG 529 70 mg IV	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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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 529 in people with Cardiovascular, 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 5 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 Jul 2019. 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?

Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (AEs) (time frame: From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.). 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 NCT03170193.

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 Jul 2019.