Investigating the effects of fosmanogepix in healthy Chinese adults

A Phase 1, Randomized, Single-center, Double-blind, Placebo-controlled Study of Fosmanogepix Administered as Single and Multiple Doses in Healthy Adult Chinese Subjects

This study is testing a new drug called fosmanogepix in healthy adults from China to see how it works in the body and if it's safe to use.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Basilea Pharmaceutica (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06961708 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the pharmacokinetics and safety of the investigational drug fosmanogepix, including its active form manogepix, in healthy adult participants from China. The study is divided into two parts: the first part involves a single dose administration, while the second part involves multiple doses given either intravenously or orally. Approximately 52 participants will be enrolled and randomly assigned to receive either the study drug or a placebo. Blood samples will be collected to analyze how the drug is processed and eliminated by the body, alongside regular health assessments.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adult Chinese individuals aged 18 to 50 with a BMI between 18.0 and 30.0 kg/m2.

Not a fit: Patients with active infections or those with medical conditions affecting drug absorption will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and pharmacokinetics of fosmanogepix, potentially leading to its use in treating infections.

How similar studies have performed: While this specific approach is novel, similar pharmacokinetic studies have shown success in evaluating new drugs in healthy populations.

Eligibility criteria

Inclusion Criteria:

* 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 are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, vital signs, creatinine, and estimated creatinine clearance (Cockcroft-Gault formula).

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.

Where this trial is running

Shanghai

• Shanghai Xuhui Central Hospital, Longchuan North Road — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Thomas Kaindl, MD

Conditions Healthy; Fosmanogepix; Manogepix; Chinese; Pharmacokinetics; Healthy adults