Single Ascending Dose Study of AMG 570 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT02618967
• Date of registration: 13/10/2015
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: Single Ascending Dose Study of AMG 570 in Healthy Subjects
• Scientific 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
• Date of first enrolment: March 28, 2016
• Target sample size: 56
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02618967
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: AMG 570

Biological: AMG 570 Matching Placebo

Primary Outcome(s)

Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations [Time Frame: Baseline to Day 105]

Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs) [Time Frame: Baseline to Day 105]

Number of Participants Who Experienced a Clinically Significant Change in Vital Signs [Time Frame: Baseline to Day 105]

Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests [Time Frame: Baseline to Day 105]

Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) [Time Frame: Day 1 to Day 105]

Secondary Outcome(s)

Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570 [Time Frame: 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]

Maximum Observed Concentration (Cmax) of AMG 570 [Time Frame: 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]

Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts [Time Frame: Baseline to Day 8; Day 29; Day 57 and Day 105]

Percentage Change From Baseline for CD19+ Total B Cells Percentages (%) [Time Frame: Baseline to Day 8; Day 29; Day 57 and Day 105]

Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570 [Time Frame: 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]

Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells [Time Frame: Day 8; Day 29; Day 57; and Day 105]

Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result [Time Frame: Baseline to Day 105]

Time to Reach Maximum Observed Concentration (Tmax) of AMG 570 [Time Frame: 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]

Secondary ID(s)

20140322

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/10/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02618967