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A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis

A Phase 1, Non-randomized, Open-label, Multi-center Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intravenous Fosmanogepix in Adult Subjects With End-stage Renal Disease Requiring Intermittent Hemodialysis

Who can join

Ages 18 to 80 · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* Body mass index of 18 to 42 kg/m2, inclusive, and a total body weight \> 50 kg at Screening.
* Subjects with normal renal function only: Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min
* Subjects with ESRD requiring IHD only: Hemodialysis treatment for at least 3 months prior to Screening, with dialysis performed ≥ 3 times per week and adequate dialysis efficiency as established by document Kt/V ≥ 1.2 on current regimen. The clinical status of the underlying ESRD should be stable

Exclusion Criteria:

* Subjects who are pregnant, breastfeeding, or plan to become pregnant during the study.
* Laboratory abnormality or other medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, that may increase the risk to study participation, or in the Investigator's judgment, make the subject inappropriate for the study.
* History or presence of clinically-significant disorders, which, in the opinion of the Investigator, are capable of significantly altering the distribution, metabolism, or elimination of the study drug.
* Renal or liver transplant recipients
* Hepatic impairment not related to ESRD
* Use of any prohibited medication within five half-lives plus 14 days prior to Day -1

Subjects with ESRD requiring IHD only:

-Not on stable dosing regimen (i.e., \< 3 weeks prior to Screening) of prescription/ non prescription drugs (including dietary/herbal supplements) for the treatment of a stable concomitant disease

About the study

This study will evaluate how fosmanogepix is processed by the body (pharmacokinetics, PK) in participants with kidney failure (end-stage renal disease (ESRD) requiring intermittent hemodialysis (IHD) compared with participants with normal kidney function (control group). Fosmanogepix is given by intravenous infusion and is converted in the body to manogepix, the active form of the drug. Fosmanogepix is an investigational and has not been approved by the United States Food and Drug Administration (FDA) or any other regulatory authority for use in humans.

The study will also evaluate the effect of hemodialysis on manogepix levels in participants with ESRD.

The safety and tolerability of fosmanogepix will also be assessed in participants with kidney failure and in matched participants with normal kidney function.

Participation in the study will last up to 11 weeks and will include up to two study periods. Participants with ESDR requiring IHD will receive fosmanogepix in two study periods. Healthy participants will receive fosmanogepix in one study period.

The study will be conducted at two study sites in the United States.

What is being tested

• Intravenous fosmanogepix (drug)
• Intravenous fosmanogepix (drug)

Sponsor: Basilea Pharmaceutica · Participants: 20 · Started: Oct 27, 2026

Contact the study team

• Thomas Kaindl, MD · Phone: +41615671505

Official record on ClinicalTrials.gov — NCT07916181

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.