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New antifungal drug fosmanogepix tested in healthy volunteers

NCT ID NCT06961708

Knowledge-focused Sponsor: Basilea Pharmaceutica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 trial studied the safety and how the body handles the experimental antifungal drug fosmanogepix in 54 healthy Chinese adults. Participants received single or multiple doses of the drug either by mouth or through an IV, or a placebo. The study measured drug levels in the blood and monitored for side effects to guide future dosing in patients with fungal infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fosmanogepix
What this could lead to
If successful, this study will provide key dosing and safety data for fosmanogepix, potentially supporting its use against serious fungal infections.
What could go wrong
This is an early Phase 1 trial in healthy volunteers, not patients. It only measures safety and drug levels, not whether the drug works against infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

54 people

The number who actually took part.

Started

Apr 2025

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

Contacts and locations

Locations

  • Shanghai Xuhui Central Hospital, Longchuan North Road

    Shanghai, 200237, China

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