A Study of Fosmanogepix in Healthy Adult Chinese Subjects

NCT06961708 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: FMGX-CP-10975A50124C00033
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate the pharmacokinetics and safety of the investigational drug fosmanogepix including its active moiety manogepix following a single dose and multiple doses (by intravenous infusion (IV) or orally) in healthy Chinese adults. The study consisted of 2 consecutive Parts (Part-1, single-dose part followed by Part-2, multiple-dose part) including a total of 54 subjects (32 subjects in Part-1 and 22 subjects in PART-2) randomized.

Conditions

Healthy

Keywords

Fosmanogepix; Manogepix; Chinese; Pharmacokinetics; Healthy adults

Outcome Measures

Primary Outcomes (8)

• Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1

  Pharmacokinetic (PK) parameter Cmax for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects

  pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose

• Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-1

  PK parameter Tmax for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects

  pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose

• Area Under the Plasma Concentration vs. Time Curve for 0-24 Hours (AUC24) of Manogepix in Part-1

  PK parameter AUC 24 for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects

  pre-dose, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Manogepix in Part-1

  PK parameter AUClast for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects

  pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Manogepix in Part-1

  PK parameter AUC (0 - ∞) for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects

  pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose

• Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-2

  PK parameter Cmax after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose from Day 2 to Day 7 or followed by an IV maintenance dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7

  pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7

• Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-2

  PK parameter Tmax after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7

  pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7

• Area Under the Concentration-time Curve at Steady State Over the Dosing Interval Tau (AUCtau) of Manogepix in Part-2

  PK parameter AUCtau after fosmanogepix administration as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose from Day 2 to Day 7 or followed by an IV maintenance dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7

  pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7

Secondary Outcomes (3)

• Fraction of Unbound Manogepix in Plasma in Part 1

  pre-dose and 3 hours postdose

• Number of Subjects With Treatment-emergent AE (TEAE) in Part-1

  Up to 36 days

• Number of Subjects With TEAE in Part-2

  Up to 42 days

Study Arms (4)

Single-dose Part -1 (Cohort 1, oral)

EXPERIMENTAL

Subjects received fosmanogepix or placebo by oral administration

Drug: Oral Fosmanogepix; Drug: oral placebo

Single-dose Part-1 (Cohort 2, IV)

EXPERIMENTAL

Subjects received fosmanogepix or placebo by IV infusion

Drug: IV Fosmanogepix; Drug: IV placebo

Multiple-dose Part-2 (Cohort 3, IV)

EXPERIMENTAL

Subjects received fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of fosmanogepix or placebo via IV infusion from Day 2 to Day 7

Drug: IV Fosmanogepix; Drug: IV placebo

Multiple-dose Part-2 (Cohort 4, IV followed by oral)

EXPERIMENTAL

The subjects received fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7.

Drug: Oral Fosmanogepix; Drug: IV Fosmanogepix; Drug: IV placebo; Drug: oral placebo

Interventions

Oral Fosmanogepix DRUG

Oral Tablet

Multiple-dose Part-2 (Cohort 4, IV followed by oral); Single-dose Part -1 (Cohort 1, oral)

IV Fosmanogepix DRUG

IV infusion

Multiple-dose Part-2 (Cohort 3, IV); Multiple-dose Part-2 (Cohort 4, IV followed by oral); Single-dose Part-1 (Cohort 2, IV)

IV placebo DRUG

Matching IV placebo

Multiple-dose Part-2 (Cohort 3, IV); Multiple-dose Part-2 (Cohort 4, IV followed by oral); Single-dose Part-1 (Cohort 2, IV)

oral placebo DRUG

Matching oral placebo

Multiple-dose Part-2 (Cohort 4, IV followed by oral); Single-dose Part -1 (Cohort 1, oral)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Basilea Pharmaceutica: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Shanghai Xuhui Central Hospital, Longchuan North Road

Shanghai, 200237, China

Location

Results Point of Contact

• Title: Thomas Kaindl, MD
• Organization: Basilea Pharmaceutica International Ltd, Allschwil

thomas.kaindl@basilea.com

+41615671505

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 8, 2025
• Study Start: April 14, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)