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Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects

NCT ID: NCT02956499

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-24

Study Completion Date

2017-07-03

Brief Summary

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First In Human (FIH), randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) escalation study of approximately 80 subjects. The SAD portion of the study will enroll six cohorts of eight healthy subjects per cohort, for a total of approximately 48 healthy subjects. The MAD portion of the study will enroll four cohorts of eight healthy subjects per cohort, for a total of approximately 32 healthy subjects.

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Detailed Description

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Conditions

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Fungal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

single intravenous dose

Group Type EXPERIMENTAL

APX001 single dose 1

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Cohort 2

single intravenous dose

Group Type EXPERIMENTAL

APX001 single dose 2

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Cohort 3

single intravenous dose

Group Type EXPERIMENTAL

APX001 single dose 3

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Cohort 4

single intravenous dose

Group Type EXPERIMENTAL

APX001 single dose 4

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Cohort 5

single intravenous dose

Group Type EXPERIMENTAL

APX001 single dose 5

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Cohort 6

single intravenous dose

Group Type EXPERIMENTAL

APX001 single dose 6

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Cohort 7

multiple intravenous doses

Group Type EXPERIMENTAL

APX001 multiple dose 1

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Cohort 8

multiple intravenous doses

Group Type EXPERIMENTAL

APX001 multiple dose 2

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Cohort 9

multiple intravenous doses

Group Type EXPERIMENTAL

APX001 multiple dose 3

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Cohort 10

multiple intravenous doses

Group Type EXPERIMENTAL

APX001 multiple dose 4

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Interventions

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APX001 single dose 1

Intervention Type DRUG

APX001 single dose 2

Intervention Type DRUG

APX001 single dose 3

Intervention Type DRUG

APX001 single dose 4

Intervention Type DRUG

APX001 single dose 5

Intervention Type DRUG

APX001 single dose 6

Intervention Type DRUG

APX001 multiple dose 1

Intervention Type DRUG

APX001 multiple dose 2

Intervention Type DRUG

APX001 multiple dose 3

Intervention Type DRUG

APX001 multiple dose 4

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Basilea Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Engelhardt

Role: STUDY_DIRECTOR

Basilea Pharmaceutica International Ltd, Allschwil

Locations

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PRA Health Sciences

Groningen, , Netherlands

Site Status

PRA Health Sciences

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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Hodges MR, Ople E, Wedel P, Shaw KJ, Jakate A, Kramer WG, Marle SV, van Hoogdalem EJ, Tawadrous M. Safety and Pharmacokinetics of Intravenous and Oral Fosmanogepix, a First-in-Class Antifungal Agent, in Healthy Volunteers. Antimicrob Agents Chemother. 2023 Apr 18;67(4):e0162322. doi: 10.1128/aac.01623-22. Epub 2023 Mar 29.

Reference Type RESULT
PMID: 36988461 (View on PubMed)

Other Identifiers

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C4791001

Identifier Type: OTHER

Identifier Source: secondary_id

APX001-101

Identifier Type: -

Identifier Source: org_study_id

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