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D3S-001

Phase 1/2

Undisclosed | Small molecule | Other |Fortrea Holdings Inc.|Trials Updated: Mar 25, 2026

D3S-001 development status

Highest phase Phase 1/2 run by D3 Bio (Wuxi) Co., Ltd (NCT05886920)
Phase scored for FTREPhase 1
Registered trials 2 across 1 sponsor since Jun 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

D3S-001 clinical trials

D3S-001 · 1 trial · 1 indication

Phase 1 1
NCT07093398A Phase 1 Study to Assess Food Effect on the Pharmacokinetics of D3S-001 in Healthy Adult ParticipantsHealthy Adult Volunteers
COMPLETED26 Analytics
PHASE1COMPLETED
A Phase 1 Study to Assess Food Effect on the Pharmacokinetics of D3S-001 in Healthy Adult Participants
Healthy Adult Volunteers
NCT0709339826
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Study Endpoints

Primary Endpoints

Maximum Observed Concentration (Cmax)
From screening to end of treatment at 34 days

Maximum Observed Concentration (Cmax) of D3S-001 administered in the fasted and fed state.

Area under the concentration-time curve
From screening to end of treatment at 34 days

Evaluate the area under the concentration-time curve from time zero to the time of the last quantifiable concentration after D3S-001 administered in the fasted and fed state.

Secondary Endpoints

Adverse events
From screening to end of study (approximately 34 days)
Number of clinically significant clinical laboratory findings
On Screening visit, Day -1, Days 2-3 and Days 5-6 (End of Study)
Number of clinically significant electrocardiogram parameters
On screening day, Day -1 and Days 1-6 (End of Study)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1 - Fasted and FedEXPERIMENTALPeriod 1 (day 1-3): Treatment A - 600mg D3S-001, following an overnight fast of at least 10 hours. Period 2 (day 4 to 6): Treatment B - 600mg D3S-001, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast.
Group 2 - Fed and FastedEXPERIMENTALPeriod 1 (day 1-3): Treatment B - 600mg D3S-001, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast. Period 2 (day 4-6): Treatment A - 600mg D3S-001, following an overnight fast of at least 10 hours.

Interventions

NameTypeDescription
D3S-001DRUGThe investigational product dose: 600 mg D3S-001 capsules. A 600-mg oral dose of D3S-001 will be given to potential participants on Day 1 and Day 4.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions. * Males or females of any race, aged between 18 to 65 years, inclusive, with a body mass index between 18.0 and 32.0 kg/m2, inclusive. * In good health, determined by ...

Countries:Australia
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