Clinical trial NCT02618967: Single Ascending Dose Study of AMG 570 in Healthy Subjects
Official title: A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Healthy Volunteer
Safety Study
Placebo Control
Phase 1
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-12-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single dose of AMG 570.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by the investigator
* Normal or clinically acceptable electrocardiogram (ECG)
* Female subjects must be of documented non-reproductive potential
* Subjects must be current for all vaccinations
* Other inclusion criteria may apply

Exclusion Criteria:

* Current or chronic history of liver disease
* History of active infections
* History of significant respiratory disorder
* Evidence of renal disease
* Other exclusion criteria may apply

Primary outcomes:
measure: Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 to Day 105
measure: Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations
timeFrame: Baseline to Day 105
measure: Number of Participants Who Experienced a Clinically Significant Change in Vital Signs
timeFrame: Baseline to Day 105
measure: Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests
timeFrame: Baseline to Day 105
measure: Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs)
timeFrame: Baseline to Day 105
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of AMG 570
timeFrame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
measure: Time to Reach Maximum Observed Concentration (Tmax) of AMG 570
timeFrame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
measure: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570
timeFrame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
measure: Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570
timeFrame: Pre-dose and 12 hours post-dose on Day 1 and days 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 57, 71 and 105
measure: Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result
timeFrame: Baseline to Day 105
measure: Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells
timeFrame: Day 8; Day 29; Day 57; and Day 105
measure: Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts
timeFrame: Baseline to Day 8; Day 29; Day 57 and Day 105
measure: Percentage Change From Baseline for CD19+ Total B Cells Percentages (%)
timeFrame: Baseline to Day 8; Day 29; Day 57 and Day 105
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Research Site
state: Indiana
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Abuqayyas L, Chen PW, Dos Santos MT, Parnes JR, Doshi S, Dutta S, Houk BE. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Properties of Rozibafusp Alfa, a Bispecific Inhibitor of BAFF and ICOSL: Analyses of Phase I Clinical Trials. Clin Pharmacol Ther. 2023 Aug;114(2):371-380. doi: 10.1002/cpt.2929. Epub 2023 May 24.