First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentauri Therapeutics Limited

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

104 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators