Phase 1
N=54
A Study of Fosmanogepix in Healthy Adult Chinese Subjects
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT06961708 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1 — 5750; 10865; 8343; 13874 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Oral Fosmanogepix (Drug); IV Fosmanogepix (Drug); IV placebo (Drug); oral placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Basilea Pharmaceutica
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1 |
5750; 10865; 8343; 13874 | — |
| PRIMARY Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-1 |
2.50; 3.00; 2.96; 2.99 | — |
| PRIMARY Area Under the Plasma Concentration vs. Time Curve for 0-24 Hours (AUC24) of Manogepix in Part-1 |
49823; 89822; 76270; 132743 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Manogepix in Part-1 |
148314; 278079; 257783; 407819 | — |
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Manogepix in Part-1 |
156539; 296639; 266920; 440974 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-2 |
14665; 16459 | — |
| PRIMARY Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-2 |
2.90; 3.50 | — |
| PRIMARY Area Under the Concentration-time Curve at Steady State Over the Dosing Interval Tau (AUCtau) of Manogepix in Part-2 |
224722; 258780 | — |
| SECONDARY Fraction of Unbound Manogepix in Plasma in Part 1 |
0.109; 0.105; 0.192; 0.226 | — |
| SECONDARY Number of Subjects With Treatment-emergent AE (TEAE) in Part-1 |
5; 3; 0; 1; 0; 0 | — |
| SECONDARY Number of Subjects With TEAE in Part-2 |
4; 7; 2; 1; 0; 0 | — |
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.
Eligibility Criteria
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 test, if deemed necessary:
- AST or ALT ≥ 1.0 × ULN.
- Total bilirubin ≥ 1.5 × ULN.
Data sourced from ClinicalTrials.gov (NCT06961708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.