Phase 1
Completed N=56
Single Ascending Dose Study of AMG 570 in Healthy Subjects
Source: ClinicalTrials.gov NCT02618967 ↗Enrolled (actual)
56
Serious AEs
1.8%
Results posted
Oct 2021
Primary outcomePrimary: Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) — 6; 5; 4; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) |
6; 5; 4; 4; 2; 3 | — |
| PRIMARY Number of Participants Who Experienced a Clinically Significant Change in Physical Examinations |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Experienced a Clinically Significant Change in Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Experienced a Clinically Significant Change in Clinical Laboratory Safety Tests |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Experienced a Clinically Significant Change in Electrocardiograms (ECGs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of AMG 570 |
0.08664; 0.624; 4.33; 6.05; 17.2; 33.5 | — |
| SECONDARY Time to Reach Maximum Observed Concentration (Tmax) of AMG 570 |
5.0; 3.0; 3.0; 5.0; 5.0; 5.0 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of AMG 570 |
0.591; 5.12; 43.8; 88.3; 271; 561 | — |
| SECONDARY Area Under the Concentration-time Curve Observed From Time Zero to Infinity (AUCinf) of AMG 570 |
0.928; 6.24; 51.1; 88.6; 284; 624 | — |
| SECONDARY Number of Participants With an Anti-AMG 570 Binding Antibody Positive Postbaseline Result |
3; 2; 1; 3; 3; 6 | — |
| SECONDARY Mean Peripheral Blood B7-Related Protein-1 (B7RP-1) Receptor Occupancy on Total B Cells |
13.73; 43.76; 64.37; 80.82; 88.87; 92.52 | — |
| SECONDARY Percentage Change From Baseline for Cluster of Differentiation (CD)19+ Total B Cells Counts |
41.333; 53.770; 66.531; 32.861; 57.123; 57.478 | — |
| SECONDARY Percentage Change From Baseline for CD19+ Total B Cells Percentages (%) |
56.111; 24.057; 28.291; 20.942; 26.538; 45.886 | — |
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
Data sourced from ClinicalTrials.gov (NCT02618967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.