The primary objective of this trial is to assess the safety and tolerability of single and multiple ascending intravenously (IV) infused doses of CTX-187 when administered to healthy adult male and female participants and participants with a bacterial infection (bronchiectasis participants chronically infected with P. aeruginosa).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
104
ICON Clinic, location GRQM
Groningen, Netherlands
RECRUITINGNumber of Participants with Treatment-emergent Adverse Events (TEAEs)
TEAEs include clinically significant abnormalities in electrocardiograms (ECGs), vital signs, clinical laboratory values and physical examination.
Time frame: Up to Day 28
Area Under the Concentration-time Curve (AUC) of CTX-187 in Plasma
Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9
Maximum Observed Plasma Concentration (Cmax) of CTX-187
Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9
Time to Attain Maximum Observed Plasma Concentration (tmax) of CTX-187
Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9
Terminal Elimination Half-life (t1/2) of CTX-187 in Plasma
Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9
Clearance (CL) of CTX-187
Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9
Volume of Distribution at Steady-state (Vss) of CTX-187
Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9
Number of Participants with Antidrug Antibodies (ADA) Against CTX-187 in Serum
Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9
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