The primary objective of this study will be to evaluate the safety and tolerability of single and multiple oral doses of CCX168, over a range of dose levels, in healthy male and female participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
48
Covance Clinical Research Unit (CRU) AG
Allschwil, Switzerland
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 43 days
Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters
Time frame: Up to 29 days
Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to 29 days
Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters
Time frame: Up to 29 days
Maximum Plasma Concentration (Cmax) of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Time of Cmax of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Terminal Phase Rate Constant of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Terminal Half-life of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Oral Clearance of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Apparent Volume of Distribution of CCX168
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
Area Under the Plasma Concentration-time Curve (AUC) of CCX168 From Time 0 to Time t
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Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
AUC of CCX168 From Time 0 to Infinity
Time frame: Period 1: Up to Day 8; Period 2: Up to Day 15
AUC of CCX168 From Time 0 to 24 Hours
Time frame: Periods 1 and 2: Up to Hour 24
AUC of CCX168 From Time 0 to 12 Hours
Time frame: Periods 1 and 2: Up to Hour 12
AUC of CCX168 From Time 12 to 24 Hours
Time frame: Periods 1 and 2: Hour 12 to Hour 24
Period 2: AUC of CCX168 From Time 0 to the end of the Dosing Interval
Time frame: Cohorts 1-3: Up to Hour 24; Cohorts 4-5: Up to Hour 12
Period 2: Accumulation Ratio of CCX168
Time frame: Up to Day 7
Percent Inhibition of complement 5a receptor (C5aR)-dependent Upregulation of CD11b in Peripheral Blood Neutrophils
Time frame: Period 1: Up to Hour 24; Period 2: Up to 12 hours after the first dose on Day 7