NCT06961708 is a Phase 1 clinical trial of Oral Fosmanogepix in Healthy, sponsored by Basilea Pharmaceutica.

Who is sponsoring NCT06961708?

NCT06961708 is sponsored by Basilea Pharmaceutica.

What drugs are being tested in NCT06961708?

Interventions in NCT06961708: Oral Fosmanogepix, IV Fosmanogepix, IV placebo, oral placebo.

Is NCT06961708 still recruiting?

NCT06961708 is currently completed. Last updated 6 April 2026.

Are results published for NCT06961708?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-04-06 · How we verify

NCT06961708

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Fosmanogepix in Healthy Adult Chinese Subjects

Completed Phase 1 Results posted Last updated 6 April 2026

What this trial tests

Phase 1 trial testing Oral Fosmanogepix in Healthy in 54 participants. Completed in 15 July 2025.

Timeline

14 April 2025

Primary endpoint
15 July 2025

15 July 2025

Quick facts

Lead sponsor	Basilea Pharmaceutica
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	basic science
Enrollment	54
Start date	14 April 2025
Primary completion	15 July 2025
Estimated completion	15 July 2025
Sites	1 location across China

Drugs / interventions tested

Oral Fosmanogepix — full drug profile →
IV Fosmanogepix — full drug profile →
IV placebo
oral placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Basilea Pharmaceutica — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Single-dose Part -1 (Cohort 1, Oral 400 mg)	5750	± 39.5
Single-dose Part -1 (Cohort 1, Oral 800 mg)	10865	± 12.9
Single-dose Part-1 (Cohort 2, IV 600 mg)	8343	± 31.1
Single-dose Part-1 (Cohort 2, IV 1000 mg)	13874	± 18.0

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

Group	Value	95% CI
Single-dose Part -1 (Cohort 1, Oral 400 mg)	2.50	2.00 – 3.00
Single-dose Part -1 (Cohort 1, Oral 800 mg)	3.00	2.00 – 4.00
Single-dose Part-1 (Cohort 2, IV 600 mg)	2.96	2.85 – 3.05
Single-dose Part-1 (Cohort 2, IV 1000 mg)	2.99	2.87 – 3.05

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

Group	Value	95% CI
Single-dose Part -1 (Cohort 1, Oral 400 mg)	49823	± 17.3
Single-dose Part -1 (Cohort 1, Oral 800 mg)	89822	± 25.3
Single-dose Part-1 (Cohort 2, IV 600 mg)	76270	± 32.3
Single-dose Part-1 (Cohort 2, IV 1000 mg)	132743	± 28.2

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

Group	Value	95% CI
Single-dose Part -1 (Cohort 1, Oral 400 mg)	148314	± 12.1
Single-dose Part -1 (Cohort 1, Oral 800 mg)	278079	± 16.8
Single-dose Part-1 (Cohort 2, IV 600 mg)	257783	± 30.5
Single-dose Part-1 (Cohort 2, IV 1000 mg)	407819	± 12.6

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

Group	Value	95% CI
Single-dose Part -1 (Cohort 1, Oral 400 mg)	156539	± 14.4
Single-dose Part -1 (Cohort 1, Oral 800 mg)	296639	± 17.7
Single-dose Part-1 (Cohort 2, IV 600 mg)	266920	± 33.4
Single-dose Part-1 (Cohort 2, IV 1000 mg)	440974	± 9.7

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

Group	Value	95% CI
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)	14665	± 17.1
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)	16459	± 7.6

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

Group	Value	95% CI
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)	2.90	2.87 – 2.97
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)	3.50	2.00 – 6.00

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

Group	Value	95% CI
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)	224722	± 24.2
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)	258780	± 8.4

Fraction of Unbound Manogepix in Plasma in Part 1 Secondary · pre-dose and 3 hours postdose

The fraction of unbound manogepix has been assessed after single dose administration (oral / IV)

Group	Value	95% CI
Single-dose Part -1 (Cohort 1, Oral 400 mg)	0.109	± 11.4
Single-dose Part -1 (Cohort 1, Oral 800 mg)	0.105	± 22.3
Single-dose Part-1 (Cohort 2, IV 600 mg)	0.192	± 27.1
Single-dose Part-1 (Cohort 2, IV 1000 mg)	0.226	± 8.2

Number of Subjects With Treatment-emergent AE (TEAE) in Part-1 Secondary · Up to 36 days

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

Group	Value	95% CI
Single-dose Part -1 (Cohort 1, Oral 400 mg)	5
Single-dose Part -1 (Cohort 1, Oral 800 mg)	3
Single-dose Part-1 (Cohort 2, IV 600 mg)	0
Single-dose Part-1 (Cohort 2, IV 1000 mg)	1
Single-dose Part-1 (Placebo)	0
Single-dose Part -1 (Cohort 1, Oral 400 mg)	0
Single-dose Part -1 (Cohort 1, Oral 800 mg)	0
Single-dose Part-1 (Cohort 2, IV 600 mg)	0
Single-dose Part-1 (Cohort 2, IV 1000 mg)	0
Single-dose Part-1 (Placebo)	0
Single-dose Part -1 (Cohort 1, Oral 400 mg)	0
Single-dose Part -1 (Cohort 1, Oral 800 mg)	0
Single-dose Part-1 (Cohort 2, IV 600 mg)	0
Single-dose Part-1 (Cohort 2, IV 1000 mg)	0
Single-dose Part-1 (Placebo)	0
Single-dose Part -1 (Cohort 1, Oral 400 mg)	1
Single-dose Part -1 (Cohort 1, Oral 800 mg)	3
Single-dose Part-1 (Cohort 2, IV 600 mg)	6
Single-dose Part-1 (Cohort 2, IV 1000 mg)	5
Single-dose Part-1 (Placebo)	8

Number of Subjects With TEAE in Part-2 Secondary · Up to 42 days

Group	Value	95% CI
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)	4
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)	7
Multiple-dose Part-2 (Placebo)	2
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)	1
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)	0
Multiple-dose Part-2 (Placebo)	0
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)	0
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)	0
Multiple-dose Part-2 (Placebo)	0
Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)	3
Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)	1
Multiple-dose Part-2 (Placebo)	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Overall up to 42 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single-dose Part -1 (Cohort 1, Oral 400 mg)

Serious: 0/6 (0%)

Deaths: 0/6

Single-dose Part -1 (Cohort 1, Oral 800 mg)

Serious: 0/6 (0%)

Deaths: 0/6

Single-dose Part-1 (Cohort 2, IV 600 mg)

Serious: 0/6 (0%)

Deaths: 0/6

Single-dose Part-1 (Cohort 2, IV 1000 mg)

Serious: 0/6 (0%)

Deaths: 0/6

Single-dose Part-1 (Placebo)

Serious: 0/8 (0%)

Deaths: 0/8

Multiple-dose Part-2 (Cohort 3, IV 1,000/600 mg)

Serious: 0/8 (0%)

Deaths: 0/8

Multiple-dose Part-2 (Cohort 4, IV 1,000/600 mg/Oral 800 mg)

Serious: 0/8 (0%)

Deaths: 0/8

Multiple-dose Part-2 (Placebo)

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (20 terms — click to expand)

Reaction	System	Single-dose Part -1 (Cohor…	Single-dose Part -1 (Cohor…	Single-dose Part-1 (Cohort…	Single-dose Part-1 (Cohort…	Single-dose Part-1 (Placebo)	Multiple-dose Part-2 (Coho…	Multiple-dose Part-2 (Coho…	Multiple-dose Part-2 (Plac…
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Regurgitation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Creatinine renal clearance decreased	Investigations	—	—	—	—	—	—	—	—
Electrocardiogram ST segment elevation	Investigations	—	—	—	—	—	—	—	—
Haemoglobin decreased	Investigations	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—
Neutrophil count increased	Investigations	—	—	—	—	—	—	—	—
White blood cell count decreased	Investigations	—	—	—	—	—	—	—	—
Drooling	Nervous system disorders	—	—	—	—	—	—	—	—
Hypoaesthesia	Nervous system disorders	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT06961708 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06961708 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Basilea Pharmaceutica
Last refreshed: 6 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06961708.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT06961708

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Healthy

Other Basilea Pharmaceutica trials

Verify against primary sources