A Study of Fosmanogepix in Healthy Adult Chinese Subjects

NCT ID: NCT06961708

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-14
• Study Completion Date: 2025-07-15

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 (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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1 (single dose)

Participants will receive fosmanogepix or placebo by oral administration

Group Type: EXPERIMENTAL

Oral Fosmanogepix

Intervention Type: DRUG

Oral Tablet

oral placebo

Intervention Type: DRUG

Matching oral placebo

Cohort 2 (single dose)

Participants will receive fosmanogepix or placebo by IV infusion

Group Type: EXPERIMENTAL

IV Fosmanogepix

Intervention Type: DRUG

IV infusion

IV placebo

Intervention Type: DRUG

Matching IV placebo

Cohort 3 (multiple dose)

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

Group Type: EXPERIMENTAL

IV Fosmanogepix

Intervention Type: DRUG

IV infusion

IV placebo

Intervention Type: DRUG

Matching IV placebo

Cohort 4 (multiple dose)

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.

Group Type: EXPERIMENTAL

Oral Fosmanogepix

Intervention Type: DRUG

Oral Tablet

IV Fosmanogepix

Intervention Type: DRUG

IV infusion

IV placebo

Intervention Type: DRUG

Matching IV placebo

oral placebo

Intervention Type: DRUG

Matching oral placebo

Interventions

Oral Fosmanogepix

Oral Tablet

Intervention Type: DRUG

IV Fosmanogepix

IV infusion

Intervention Type: DRUG

IV placebo

Matching IV placebo

Intervention Type: DRUG

oral placebo

Matching oral placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Basilea Pharmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Xuhui Central Hospital, Longchuan North Road

Shanghai, , China

Countries

China

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

FMGX-CP-109

Identifier Type: -

Identifier Source: org_study_id