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

Официальное название

A Phase 1 First-In-Human, Double-Blind, Single and Multiple Ascending Dose Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravenous Doses of CTX-187 in Healthy Volunteers Followed by Multiple Doses in Patients With a Bacterial Infection

Обзор

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).

Вмешательства

• Препарат Placebo
  Placebo will be administered via IV infusion.
• Препарат CTX-187
  CTX-187 will be administered via IV infusion.

Первичные конечные точки

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to Day 28]

Вторичные конечные точки (7)

• Area Under the Concentration-time Curve (AUC) of CTX-187 in Plasma [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9]
• Clearance (CL) of CTX-187 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9]

Критерии участия

Критерии включения

• 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/m\^2 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.
• Part C: Prior clinical and computerized tomography diagnosis of bronchiectasis.
• Part C: P. aeruginosa in sputum, bronchoalveolar lavage or another airway sample at least once in the 12 months prior to screening and P. aeruginosa in sputum during screening, both of which should be at least 21 days apart.
• Part C: Otherwise in good physical and mental health without clinically significant abnormalities.

Критерии исключения

• 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.
• Parts A, B and C: Known clinical diagnosis of cystic fibrosis, active allergic bronchopulmonary aspergillosis or active tuberculosis or nontuberculous mycobacterial infection; primary diagnosis of asthma or chronic obstructive pulmonary disease.
• Part C: Treatment with long term inhaled, systemic or nebulized anti-pseudomonal antibiotics which are newly initiated within the previous 3 months prior to screening.
• Part C: Receipt of anti-pseudomonal antibiotics for an exacerbation during the screening period.
• Part C: History or presence of unstable co-morbidities: 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. Participants on stable doses of anti-hypertensive medications or statins may be included following discussion between the Investigator and the medical monitor.
• Part C: History of known or suspected Clostridioides difficile infection or diarrhoea within one week of recruitment, not resolved during the past 5 days.
• Part C: Participants with an acute exacerbation of bronchiectasis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Нидерланды · 1 центр

• ICON Clinic, location GRQM — Groningen

Идентификаторы

NCT: NCT07708116 · CTX-187-101 · 224842/Z/21/Z · Agmt dtd 1/30/2023 · NNF23SA0088536 · Agmt dtd 5/19/2025 · CP-CA 25-79 · OTA No. 75A50122C00028 · 2026-525619-15-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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