A Study of Fosmanogepix in Healthy Adult Chinese Subjects

Basilea Pharmaceutica

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Oral Fosmanogepix; Drug: IV placebo; Drug: IV Fosmanogepix; Drug: oral placebo

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT06961708

FMGX-CP-109

Details and patient eligibility

About

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 (by intravenous infusion (IV) or orally) in healthy Chinese adults.

The study consists of 2 consecutive Parts (Part-1, single-dose part followed by Part-2, multiple-dose part) including a total of approximately 52 participants.

Part-1 duration will be up to 64 days including 4 visits at the clinical site and Part-2 duration will be up to 70 days including 5 visits at the clinical site. The study will include a total of 4 study sub-groups (Cohorts 1-4) in which fosmanogepix or placebo will be administered in different strengths orally or IV.

Participants will be enrolled and randomly assigned to study drug.

During the study, serial blood samples will be collected to understand how fosmanogepix is changed and eliminated from the body. Participants will also receive physical examination and other tests. This will help to understand if fosmanogepix is safe.

All data analyses will be descriptive (no statistical analysis will be provided).

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

54 participants in 4 patient groups

Cohort 1 (single dose)

Experimental group

Description:

Participants will receive fosmanogepix or placebo by oral administration

Treatment:

Drug: oral placebo

Drug: Oral Fosmanogepix

Cohort 2 (single dose)

Experimental group

Description:

Participants will receive fosmanogepix or placebo by IV infusion

Treatment:

Drug: IV Fosmanogepix

Drug: IV placebo

Cohort 3 (multiple dose)

Experimental group

Description:

Participants will receive fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of fosmanogepix or placebo via IV infusion from Day 2 to Day 7

Treatment:

Drug: IV Fosmanogepix

Drug: IV placebo

Cohort 4 (multiple dose)

Experimental group

Description:

The participants will receive fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7.

Treatment:

Drug: oral placebo

Drug: IV Fosmanogepix

Drug: IV placebo

Drug: Oral Fosmanogepix