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Inflammatory DiseasesPhase 1NCT04987333

Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants

A Phase 1 study testing Efavaleukin alfa in people with Inflammatory Diseases, run by Amgen at 1 site in United Kingdom.

Completed

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

Official record
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Trial summary

The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Inflammatory Diseases
What is being tested?
Efavaleukin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited Kingdom
Study dates
9 Aug 2021to 3 Oct 2022
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 male or female participants, between 18 and 55 years of age (inclusive) at the time of Screening.
  • Chinese, Japanese, or Caucasian participant:
  • Chinese participants must be of Chinese ancestry (4 grandparents and biological parents).
  • Japanese participants must be first- or second-generation Japanese (4 grandparents and biological parents; participant or both of their parents must have been born in Japan).
  • Caucasian participants are those who self-identify exclusively as such on the electronic case report form (eCRF) and also identify their biological parents as such.
  • In good health, determined by no clinically significant findings from medical history, physical examinations, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) as assessed by the Investigator (or designee).
  • Body mass index between 17 and 30 kg/m^2 (inclusive) at the time of Screening.

Who cannot join

  • Evidence of scars, tattoos, or other skin lesions that may interfere with the injection site or injection site assessments.
  • History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in.
  • A QT interval corrected for heart rate using Fridericia's method (QTcF) interval > 450 msec in male participants or > 470 msec in female participants or history/evidence of long QT syndrome, at Screening or Check-in.
  • PR interval > 210 msec, at Screening or Check-in.
  • Second- or third-degree atrioventricular (AV) block , at Screening or Check-in.
  • Systolic blood pressure (BP) > 140 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg, or HR > 100 bpm, at Screening or Check-in.
Show all 18Show fewer
  • Estimated glomerular filtration rate less than 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease equation, at Screening.
  • HbA1C ≥ 7%, at Screening or Check-in.
  • Participants who have received live vaccines within 5 weeks prior to Screening, or plan to receive live vaccines within 105 days after administration of an investigational product.
  • Positive hepatitis B or hepatitis C panel (ie, positive hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibody) at Screening, or a medical history for hepatitis B or C; and/or positive human immunodeficiency virus test, at Screening. Participants whose results are compatible with prior vaccination may be included. Participants with a history of hepatitis B vaccination without a history of hepatitis B or C are allowed to participate.
  • Consumption of foods and beverages containing poppy seeds within 7 days prior to Check-in.
  • History of alcoholism or drug/chemical abuse within 1 year prior to Check-in.
  • Use of tobacco- or nicotine-containing products within 6 months prior to Check-in.
  • Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Screening or Check-in.
  • Female participants with a positive pregnancy test at Screening or Check-in.
  • Participant has received a dose of an investigational drug within the past 90 days or 5 half-lives of the drug, whichever is longer, prior to Check-in.
  • Donation of blood from 90 days prior to Check-in, plasma from 2 weeks prior to Check-in, or platelets from 6 weeks prior to Check-in.
  • Participants with abnormal laboratory results for alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (ie, > upper limit of normal) and total bilirubin (ie, > upper limit of normal) at Screening and Check-in.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Labcorp Clinical Research Unit - Leeds

    Leeds, LDS, LS2 9LH

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open-label, Sequential-group, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 592 Administered Subcutaneously in Healthy Chinese, Japanese, and Caucasian Subjects

The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.

Being tested
Efavaleukin alfa
Keywords
Systemic lupus erythematosus (SLE), Steroid-refractory chronic graft-versus-host disease (GvHD), Ulcerative colitis, Single-dose study, Efavaleukin alfa, Regulatory T Cells (Tregs), Inflammatory
Medical subject headings
Lupus Erythematosus, Systemic, Colitis, Ulcerative

What participants receive

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

  • Efavaleukin alfaDrug

    Administered as a single dose SC injection.

Study groups in NCT04987333
Study groupRoleWhat they receive
Group 1: Chinese participants - efavaleukin alfa dose level 1ExperimentalChinese participants will receive a single dose of efavaleukin alfa at dose level 1.
Receives: Drug: Efavaleukin alfa
Group 2: Chinese participants - efavaleukin alfa dose level 2ExperimentalChinese participants will receive a single dose of efavaleukin alfa at dose level 2.
Receives: Drug: Efavaleukin alfa
Group 3: Japanese participants - efavaleukin alfa dose level 2ExperimentalJapanese participants will receive a single dose of efavaleukin alfa at dose level 2.
Receives: Drug: Efavaleukin alfa
Group 4: Caucasian participants - efavaleukin alfa dose level 2ExperimentalCaucasian participants will receive a single dose of efavaleukin alfa at dose level 2.
Receives: Drug: Efavaleukin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa

    Blood samples were collected to determine PK parameters.

    Measured: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43

  2. Time of the Maximum Observed Serum Concentration (Tmax) of Efavaleukin Alfa

    Blood samples were collected to determine PK parameters.

    Measured: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43

  3. Area Under the Serum Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Efavaleukin Alfa

    Blood samples were collected to determine PK parameters.

    Measured: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43

  4. Area Under the Serum Concentration Time Curve From Time Zero to Infinity (AUCinf) of Efavaleukin Alfa

    Blood samples were collected to determine PK parameters.

    Measured: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 43

Secondary outcomes (2)

  1. Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)

    Adverse events (AEs) were defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were any event that occurred after the participant had received study treatment. Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs were recorded as TEAEs.

    Serious AEs (SAEs) were defined as any event that met at least 1 of the following serious criteria:

    • Resulted in death (fatal)
    • Required in-patient hospitalization or prolongation of existing hospitalization
    • Resulted in persistent or significant disability/incapacity
    • A congenital anomaly/birth defect
    • Other medically important serious event

    Measured: Day 1 to Day 43

  2. Number of Participants With Anti-Efavaleukin Alfa Antibodies and Anti-Interleukin 2 (IL-2) Antibodies

    Number of participants who tested positive for developing anti-efavaleukin alfa antibodies and/or anti-IL2 antibodies at 1 or more post-baseline time points, who had a negative or no result at baseline.

    Measured: Day 1 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.

  1. First posted3 Aug 2021
  2. Study start9 Aug 2021
  3. Primary completion3 Oct 2022
  4. Study completion3 Oct 2022

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04987333
Sponsor's protocol ID
20200102
Status last verified
Oct 2023
First submitted
26 Jul 2021
Last updated
29 Mar 2024
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Efavaleukin alfa in people with Inflammatory Diseases, run by Amgen at 1 site in United Kingdom.

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 7 inclusion and 18 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 29 Mar 2024. 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 Kingdom. 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. 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 29 Mar 2024). 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?

Maximum Observed Serum Concentration (Cmax) of Efavaleukin Alfa (time frame: Day 1: Pre-dose, 6, 12, & 16 hours post-dose, and days 2 (24 hours post-dose), 3, 4, 5, 6, 8, 11, 15, 22, 29 and 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?

On the ClinicalTrials.gov record for NCT04987333.

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 29 Mar 2024.

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