Study Complete
Sponsor ID
CL001_168

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants

Sponsor ID
CL001_168
Clinicaltrials.gov ID
NCT05984251
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
48
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants Experiencing Adverse Events (AEs)

Timeframe: Up to 43 days

Number of Participants Experiencing Clinically Significant Changes in Laboratory Parameters

Timeframe: Up to 29 days

Number of Participants Experiencing Clinically Significant Changes in Electrocardiogram (ECG) Parameters

Timeframe: Up to 29 days

Number of Participants Experiencing Clinically Significant Changes in Vital Sign Parameters

Timeframe: Up to 29 days

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) of CCX168

Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15

Time of Cmax of CCX168

Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15

Terminal Phase Rate Constant of CCX168

Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15

Apparent Terminal Half-life of CCX168

Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15

Apparent Oral Clearance of CCX168

Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15

Apparent Volume of Distribution of CCX168

Timeframe: 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

Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15

AUC of CCX168 From Time 0 to Infinity

Timeframe: Period 1: Up to Day 8; Period 2: Up to Day 15

AUC of CCX168 From Time 0 to 24 Hours

Timeframe: Periods 1 and 2: Up to Hour 24

AUC of CCX168 From Time 0 to 12 Hours

Timeframe: Periods 1 and 2: Up to Hour 12

AUC of CCX168 From Time 12 to 24 Hours

Timeframe: Periods 1 and 2: Hour 12 to Hour 24

Period 2: AUC of CCX168 From Time 0 to the end of the Dosing Interval

Timeframe: Cohorts 1-3: Up to Hour 24; Cohorts 4-5: Up to Hour 12

Period 2: Accumulation Ratio of CCX168

Timeframe: Up to Day 7

Percent Inhibition of complement 5a receptor (C5aR)-dependent Upregulation of CD11b in Peripheral Blood Neutrophils

Timeframe: Period 1: Up to Hour 24; Period 2: Up to 12 hours after the first dose on Day 7

Locations

Location
Status
Contact Us
Location
Covance Clinical Research Unit (CRU) AG
Allschwil, Switzerland, CH-4123
Status
Completed