Status:
COMPLETED
A Study of Fosmanogepix in Healthy Adult Chinese Subjects
Lead Sponsor:
Basilea Pharmaceutica
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the pharmacokinetics and safety of the investigational drug fosmanogepix including its active moiety manogepix following a single dose and multiple doses (b...
Eligibility Criteria
Inclusion
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive, and a total body weight \> 45 kg for females and \> 50 kg for males at Screening.
- Subjects who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, vital signs, creatinine, and estimated creatinine clearance (Cockcroft-Gault formula).
Exclusion
- Active acute or chronic infection, including, but not limited to upper airway infection, urinary tract infection, or skin infection at Screening.
- Any condition possibly affecting drug absorption.
- Medical history of neurological disorders including abnormal movements or seizures.
- Use of prescription or non-prescription drugs, including vaccines, and dietary and herbal supplements from Screening or within five half-lives (whichever is longer) prior to the first dose of study drug and throughout the study.
- Screening supine blood pressure (BP) ≥ 140 mmHg (systolic) or ≥ 90 mmHg (diastolic), and pulse rate (PR) \> 100 beats per minute (bpm) or \< 50 bpm, following at least 5 minutes of supine rest.
- Body temperature higher than 37.5 °C.
- Screening supine 12 lead ECG demonstrating clinically relevant abnormalities that may affect subject safety or interpretation of study results.
- Subjects with any of the following abnormalities in clinical laboratory tests at Screening, as assessed by the local laboratory and confirmed by a single repeat test, if deemed necessary:
- AST or ALT ≥ 1.0 × ULN.
- Total bilirubin ≥ 1.5 × ULN.
Key Trial Info
Start Date :
April 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06961708
Start Date
April 14 2025
End Date
July 15 2025
Last Update
August 8 2025
Active Locations (1)
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1
Shanghai Xuhui Central Hospital, Longchuan North Road
Shanghai, China, 200237