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).
Parts A and B: Healthy adult males and/or females, 18 to 65 years of age.
Parts A and B: Body mass index (BMI): ≥18.0 and ≤32.0 kg/m² and weight >50 kg.
Parts A and B: Good physical and mental health without clinically significant abnormalities.
Part C: Adult males and/or females, 18 to 75 years of age.
Parts A and B: Previous participation in the current trial.
Parts A and B: History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant.
Parts A and B: Participation in a drug trial within the previous 30 days before the first dose of trial drug or 5x elimination half-life, if known, whichever is longer.
Part C: Known hypersensitivity to any reagents contained in CTX-187 or documented hypersensitivity reaction or anaphylaxis to any medication.
Parallel
Placebo
DrugPlacebo will be administered via IV infusion.
CTX-187
DrugCTX-187 will be administered via IV infusion.
6
Treatment groupsSee each treatment group below.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
TEAEs include clinically significant abnormalities in electrocardiograms (ECGs), vital signs, clinical laboratory values and physical examination.
Area Under the Concentration-time Curve (AUC) of CTX-187 in Plasma
Maximum Observed Plasma Concentration (Cmax) of CTX-187
Time to Attain Maximum Observed Plasma Concentration (tmax) of CTX-187
Terminal Elimination Half-life (t1/2) of CTX-187 in Plasma
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