A Study of Fosmanogepix in Healthy Adult Chinese Subjects
NCT06961708 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2026-04-06
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.
Conditions
- Healthy
Interventions
- DRUG
-
Oral Fosmanogepix
Oral Tablet
- DRUG
-
IV Fosmanogepix
IV infusion
- DRUG
-
IV placebo
Matching IV placebo
- DRUG
-
oral placebo
Matching oral placebo
Sponsors & Collaborators
-
Biomedical Advanced Research and Development Authority
collaborator FED -
Basilea Pharmaceutica
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-04-14
- Primary Completion
- 2025-07-15
- Completion
- 2025-07-15
- FDA Drug
- Yes
Countries
- China
Study Locations
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