A Study of Fosmanogepix in Healthy Adult Chinese Subjects (NCT06961708) | Clinical Trial Compass
CompletedPhase 1
A Study of Fosmanogepix in Healthy Adult Chinese Subjects
China54 participantsStarted 2025-04-14
Plain-language summary
The purpose of this study was to investigate the pharmacokinetics and safety of the investigational drug fosmanogepix including its active moiety manogepix following a single dose and multiple doses (by intravenous infusion (IV) or orally) in healthy Chinese adults.
The study consisted of 2 consecutive Parts (Part-1, single-dose part followed by Part-2, multiple-dose part) including a total of 54 subjects (32 subjects in Part-1 and 22 subjects in PART-2) randomized.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main criteria for inclusion and exclusion:
* 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 were overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, vital signs, creatinine, and estimated creatinine clearance (Cockcroft-Gault formula).
Main exclusion criteria:
* 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 t…
What they're measuring
1
Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1