bronchiectasis, colonized with Pseudomonas aeruginosa
Conditions
Interventions
Investigational Medicinal Product infusion
Sponsors
Hanada Ryuzo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Provision of signed and dated, written informed consent prior to any study-specific procedures, as described in Appendix A3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 2 Healthy Japanese male and female participants aged 18 to 60 years at screening with suitable veins for cannulation or repeated venipuncture. 3 Women of childbearing Potential must have a negative pregnancy test at screening and on admission to the site.
Exclusion criteria
Exclusion criteria: 1 History of any clinically important disease or disorder which, in the opinion of the PI, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. 2 History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. 3 History of malignancy, other than treated non-melanoma skin cancers or locally-treated cervical cancer, in the previous 5 years. 4 Any clinically important illness, chronic infections (eg, urinary tract infection) or individuals who are at increased risk of infection (eg, surgery, trauma, severe dental disease, or significant infection) within 30 days of screening. 5 Any laboratory values with the following deviations at screening or on admission to the site. Abnormal values may be repeated once at the discretion of the PI: (a) ALT 1.5 x ULN or more. (b) AST 1.5 x ULN or more. (c) eGFR 80 mL/min/1.73 m2 or less, as calculated using the estimate using the CKD-EPI 2021 equation. (d) WBC LLN or less, unless judged by the PI not to be out of range. (e) Hemoglobin LLN or less. (f) Platelet count LLN or less.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - AEs, SAEs, and AESIs. - Safety laboratory parameters (hematology, clinical chemistry, and urinalysis). - 12-lead ECG and cardiac rhythm monitoring (12-lead safety ECG). - Vital signs (BP, pulse rate, body temperature, respiratory rate, and SpO2) | — |
Contacts
Public ContactRyuzo Hanada
Souseikai Sumida Hospital
Outcome results
None listed