About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Placebo
- CTX-187
Treatment groups
6
Treatment groupsSee each treatment group below.