HealthyPhase 1NCT06961708

A Study of Fosmanogepix in Healthy Adult Chinese Subjects

A Phase 1 study testing Oral Fosmanogepix and IV Fosmanogepix in people with Healthy, run by Basilea Pharmaceutica at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Oral Fosmanogepix and IV Fosmanogepix
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteChina
Study dates: 14 Apr 2025to 15 Jul 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Main criteria for inclusion and exclusion:

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).

Main 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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Xuhui Central Hospital, Longchuan North Road
Shanghai, 200237

Other trials in China

About this study

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

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.

Read the detailed description

Part-1 duration including screening period was up to 64 days including 4 visits at the clinical site and Part-2 duration including screening period was up to 70 days including 5 visits at the clinical site. The study included a total of 4 study sub-groups (Cohorts 1-4) in which fosmanogepix or placebo was administered in different strengths orally or IV.

Subjects were enrolled and randomly assigned to study drug.

During the study, serial blood samples were collected to understand how fosmanogepix was changed and eliminated from the body.

The primary objective of PART-1 (Single-dose) was to evaluate the pharmacokinetic (PK) profile of manogepix (active moiety of fosmanogepix) after single dose administration in healthy adult Chinese subjects.

The primary objective of PART-2 (Multiple-dose) was to evaluate the PK profile of manogepix (active moiety of fosmanogepix) after repeated doses in healthy adult Chinese subjects.

All data analyses are descriptive (no statistical analysis is provided).

Conditions: Healthy
Being tested: Oral Fosmanogepix, IV Fosmanogepix, IV placebo, oral placebo
Keywords: Fosmanogepix, Manogepix, Chinese, Pharmacokinetics, Healthy adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral FosmanogepixDrug
Oral Tablet
IV FosmanogepixDrug
IV infusion
IV placeboDrug
Matching IV placebo
oral placeboDrug
Matching oral placebo

Study groups in NCT06961708
Study group	Role	What they receive
Single-dose Part -1 (Cohort 1, oral)	Experimental	Subjects received fosmanogepix or placebo by oral administration Receives: Drug: Oral Fosmanogepix; Drug: oral placebo
Single-dose Part-1 (Cohort 2, IV)	Experimental	Subjects received fosmanogepix or placebo by IV infusion Receives: 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 Receives: 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. Receives: Drug: Oral Fosmanogepix; Drug: IV Fosmanogepix; Drug: IV placebo; Drug: oral placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
The fraction of unbound manogepix has been assessed after single dose administration (oral / IV)
Measured: pre-dose and 3 hours postdose
Number of Subjects With Treatment-emergent AE (TEAE) in Part-1
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
Measured: Up to 36 days
Number of Subjects With TEAE in Part-2
A TEAE was defined as any event not present prior to the first administration of the study drug, or any event already present that worsens in either severity or frequency following exposure to the study drug
Measured: Up to 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 202515 Jul 2025

First posted8 May 2025
Study start14 Apr 2025
Primary completion15 Jul 2025
Study completion15 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06961708
Sponsor's protocol ID: FMGX-CP-109
Other IDs: 75A50124C00033
Status last verified: Mar 2026
First submitted: 24 Apr 2025
Last updated: 6 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Single-center, Double-blind, Placebo-controlled Study of Fosmanogepix Administered as Single and Multiple Doses in Healthy Adult Chinese Subjects
ClinicalTrials.gov ID: NCT06961708
Acronym / sponsor ID: FMGX-CP-109
Conditions: Healthy
Keywords: Fosmanogepix, Manogepix, Chinese, Pharmacokinetics, Healthy adults
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Basilea PharmaceuticaIndustry (pharma, biotech, devices)
Collaborators: Biomedical Advanced Research and Development Authority
Study start: 14 Apr 2025 (actual)
Primary completion: 15 Jul 2025 (actual)
Study completion: 15 Jul 2025 (actual)
First posted: 8 May 2025 (actual)
Results: Posted 11 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects were enrolled and randomly assigned to study drug.

During the study, serial blood samples were collected to understand how fosmanogepix was changed and eliminated from the body.

The primary objective of PART-2 (Multiple-dose) was to evaluate the PK profile of manogepix (active moiety of fosmanogepix) after repeated doses in healthy adult Chinese subjects.

All data analyses are descriptive (no statistical analysis is provided).

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Single-dose Part -1 (Cohort 1, oral)	Experimental	Drug: Oral Fosmanogepix, Drug: oral placeboSubjects received fosmanogepix or placebo by oral administration
Single-dose Part-1 (Cohort 2, IV)	Experimental	Drug: IV Fosmanogepix, Drug: IV placeboSubjects received fosmanogepix or placebo by IV infusion
Multiple-dose Part-2 (Cohort 3, IV)	Experimental	Drug: IV Fosmanogepix, Drug: IV placeboSubjects 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
Multiple-dose Part-2 (Cohort 4, IV followed by oral)	Experimental	Drug: Oral Fosmanogepix, Drug: IV Fosmanogepix, Drug: IV placebo, Drug: oral placeboThe 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral FosmanogepixOral Tablet	Drug	Multiple-dose Part-2 (Cohort 4, IV followed by oral), Single-dose Part -1 (Cohort 1, oral)
IV FosmanogepixIV infusion	Drug	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 placeboMatching IV placebo	Drug	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 placeboMatching oral placebo	Drug	Multiple-dose Part-2 (Cohort 4, IV followed by oral), Single-dose Part -1 (Cohort 1, oral)

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1
Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose
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
Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-1
Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose
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
Area Under the Plasma Concentration vs. Time Curve for 0-24 Hours (AUC24) of Manogepix in Part-1
Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose
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
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Manogepix in Part-1
Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose
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
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Manogepix in Part-1
Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose
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
Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-2
Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7
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
Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-2
Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7
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
Area Under the Concentration-time Curve at Steady State Over the Dosing Interval Tau (AUCtau) of Manogepix in Part-2
Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7
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

3 secondary outcomes

Fraction of Unbound Manogepix in Plasma in Part 1
Time frame: pre-dose and 3 hours postdose
Number of Subjects With Treatment-emergent AE (TEAE) in Part-1
Time frame: Up to 36 days
Number of Subjects With TEAE in Part-2
Time frame: Up to 42 days

Results and safety

Results posted to the registry on 11 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single-dose Part -1 (Cohort 1, Oral 400 mg)	6	6
Single-dose Part -1 (Cohort 1, Oral 800 mg)	6	6
Single-dose Part-1 (Cohort 2, IV 600 mg)	6	6
Single-dose Part-1 (Cohort 2, IV 1000 mg)	6	6
Single-dose Part-1 (Placebo)	8	8
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)	9	7
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)	9	8
Multiple-dose Part-2 (Placebo)	4	4

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1

Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Single-dose Part -1 (Cohort 1, Oral 400 mg) n = 6	Single-dose Part -1 (Cohort 1, Oral 800 mg) n = 6	Single-dose Part-1 (Cohort 2, IV 600 mg) n = 6	Single-dose Part-1 (Cohort 2, IV 1000 mg) n = 6
Value	5750 (39.5)	10865 (12.9)	8343 (31.1)	13874 (18.0)

Population analysed: PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group

Primary outcome: Time to Peak Manogepix Concentration (Tmax) of Manogepix in Part-1

Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose. Median (Full Range). Unit: hour

Measure	Single-dose Part -1 (Cohort 1, Oral 400 mg) n = 6	Single-dose Part -1 (Cohort 1, Oral 800 mg) n = 6	Single-dose Part-1 (Cohort 2, IV 600 mg) n = 6	Single-dose Part-1 (Cohort 2, IV 1000 mg) n = 6
Value	2.50 (2.00 to 3.00)	3.00 (2.00 to 4.00)	2.96 (2.85 to 3.05)	2.99 (2.87 to 3.05)

Population analysed: PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group

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

Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Single-dose Part -1 (Cohort 1, Oral 400 mg) n = 6	Single-dose Part -1 (Cohort 1, Oral 800 mg) n = 6	Single-dose Part-1 (Cohort 2, IV 600 mg) n = 6	Single-dose Part-1 (Cohort 2, IV 1000 mg) n = 6
Value	49823 (17.3)	89822 (25.3)	76270 (32.3)	132743 (28.2)

Population analysed: PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group

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

Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Single-dose Part -1 (Cohort 1, Oral 400 mg) n = 6	Single-dose Part -1 (Cohort 1, Oral 800 mg) n = 6	Single-dose Part-1 (Cohort 2, IV 600 mg) n = 6	Single-dose Part-1 (Cohort 2, IV 1000 mg) n = 6
Value	148314 (12.1)	278079 (16.8)	257783 (30.5)	407819 (12.6)

Population analysed: PK set included all subjects in the Safety set in Part-1, except for the ones in the placebo group

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Overall up to 42 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-dose Part -1 (Cohort 1, Oral 400 mg)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Single-dose Part -1 (Cohort 1, Oral 800 mg)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Single-dose Part-1 (Cohort 2, IV 600 mg)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Single-dose Part-1 (Cohort 2, IV 1000 mg)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Single-dose Part-1 (Placebo)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
Multiple-dose Part-2 (Placebo)	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oral Fosmanogepix and IV Fosmanogepix in people with Healthy, run by Basilea Pharmaceutica at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1 (time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06961708.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.