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New antifungal drug APX001 passes first safety check in humans

NCT ID NCT02956499

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This early-stage trial tested the safety and tolerability of a new antifungal drug called APX001 in 200 healthy volunteers. Participants received either single or multiple doses of the drug or a placebo. The study focused on side effects and how the drug moves through the body, not on treating infections. It is a necessary first step before testing the drug 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
APX001
What this could lead to
If successful, this could lead to a new treatment option for serious fungal infections, especially for patients who don't respond to current medicines.
What could go wrong
This is a very early Phase 1 trial in healthy people, not patients. It only checks safety and dosing, not whether the drug actually works against infections. Many drugs fail in later stages.

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

200 people

The number who actually took part.

Started

May 2016

Finished

Jul 2017

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 55 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.

Inclusion Criteria: * Women of childbearing potential must agree to avoid pregnancy during the study and to use contraception at least 2 weeks before the start of the study until 3 months after the last dose of study drug. * Males with partner(s) of childbearing potential must agree to use appropriate barrier contraception from the screening period until 3 months after the last dose of study drug. * Screening hematology, clinical chemistry, coagulation and urinalysis consistent with overall good health. * No significantly abnormal findings on physical examination, ECG and vital signs. * Willing and able to provide written informed consent. Exclusion Criteria: * Any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential. * History or presence of malignancy within the past year. Subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled. * Use of prescription medication within 14 days prior to the first dose of study drug and throughout the study. * Use of non-prescription or over-the-counter medications within 7 days prior to the first dose of study drug and throughout the study. * Positive results on any of the following Screening laboratory tests: serum pregnancy test, urine alcohol test, urine drugs of abuse, hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.

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Conditions

The condition(s) this trial relates to.

fungal infectious disease

As listed by the trial registrant

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

Fungal infection

Contacts and locations

Locations

  • PRA Health Sciences

    Groningen, 9728 NZ, Netherlands

  • PRA Health Sciences

    Groningen, Netherlands

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