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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07093398




Registration number
NCT07093398
Ethics application status
Date submitted
10/07/2025
Date registered
30/07/2025
Date last updated
29/09/2025

Titles & IDs
Public title
A Phase 1 Study to Assess Food Effect on the Pharmacokinetics of D3S-001 in Healthy Adult Participants
Scientific title
A Phase 1 Open-label, Randomised, Crossover Study to Assess the Effect of Food on the Pharmacokinetics (PK) of D3S-001 in Healthy Adult Participants
Secondary ID [1] 0 0
D3S-001-CP003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Adult Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - D3S-001

Experimental: Group 1 - Fasted and Fed - Period 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.

Experimental: Group 2 - Fed and Fasted - Period 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.


Treatment: Drugs: D3S-001
The 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Observed Concentration (Cmax)
Timepoint [1] 0 0
From screening to end of treatment at 34 days
Primary outcome [2] 0 0
Area under the concentration-time curve
Timepoint [2] 0 0
From screening to end of treatment at 34 days
Secondary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
From screening to end of study (approximately 34 days)
Secondary outcome [2] 0 0
Number of clinically significant clinical laboratory findings
Timepoint [2] 0 0
On Screening visit, Day -1, Days 2-3 and Days 5-6 (End of Study)
Secondary outcome [3] 0 0
Number of clinically significant electrocardiogram parameters
Timepoint [3] 0 0
On screening day, Day -1 and Days 1-6 (End of Study)
Secondary outcome [4] 0 0
To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs.
Timepoint [4] 0 0
On screening day, Day -1 and Days 1-6 (End of Study)
Secondary outcome [5] 0 0
To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs.
Timepoint [5] 0 0
On screening day, Day -1 and Days 1-6 (End of Study)
Secondary outcome [6] 0 0
To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs.
Timepoint [6] 0 0
On screening day, Day -1 and Days 1-6 (End of Study)
Secondary outcome [7] 0 0
To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs.
Timepoint [7] 0 0
On screening day, Day -1 and Days 1-6 (End of Study)
Secondary outcome [8] 0 0
Number of clinically significant physical examinations
Timepoint [8] 0 0
On Screening visit, Day -1 and Day 6 (End of Study)

Eligibility
Key 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 no clinically significant findings.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
* History of stomach or intestinal surgery (including but not limited to cholecystectomy) or resection that would potentially alter absorption and/or excretion of orally administered drugs.
* Unable or unwilling to consume the protocol-specified high-fat breakfast.

Other protocol inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
D3 Bio (Wuxi) Co., Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Fortrea
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Polasek, MD
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tanya van der Walt
Address 0 0
Country 0 0
Phone 0 0
+61 499 183 737
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07093398