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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05885451




Registration number
NCT05885451
Ethics application status
Date submitted
23/05/2023
Date registered
2/06/2023
Date last updated
2/06/2023

Titles & IDs
Public title
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants
Scientific 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
Secondary ID [1] 0 0
20180132
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Graft-versus-Host Disease (cGVHD) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 592
Other interventions - Placebo

Experimental: Arm 1: AMG 592 Dose 1 - Participants will receive AMG 592 dose 1 subcutaneously

Experimental: Arm 2: AMG 592 Dose 2 - Participants will receive AMG 592 dose 2 subcutaneously

Placebo Comparator: Arm 3: Placebo - Participants will receive placebo subcutaneously


Treatment: Drugs: AMG 592
Administered as SC injection

Other interventions: Placebo
Administered as SC injection
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Observed Serum Concentration (Cmax) of AMG 592
Timepoint [1] 0 0
Up to Day 43
Primary outcome [2] 0 0
Time of Maximum Observed Concentration (tmax) of AMG 592
Timepoint [2] 0 0
Up to Day 43
Primary outcome [3] 0 0
Area Under the Serum Concentration-time Curve to the Last Measurable Point (AUClast) of AMG 592
Timepoint [3] 0 0
Up to Day 43
Primary outcome [4] 0 0
Area Under the Concentration-time Curve (AUC) from Time Zero to Infinity (AUCinf)
Timepoint [4] 0 0
Up to Day 43
Secondary outcome [1] 0 0
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Day 1 to Day 43
Secondary outcome [2] 0 0
Number of Participants who Experience Anti-AMG 592 Antibodies Formation
Timepoint [2] 0 0
Up to Day 43

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/04/2019
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05885451
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries