A Phase 1 Study to Assess Food Effect on the Pharmacokinetics of D3S-001 in Healthy Adult Participants

NCT07093398 | Completed Phase 1

• 1 other identifier: D3S-001-CP003
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to Assess the Effect of Food on the Pharmacokinetics (PK) of D3S-001 in Healthy Adult Participants. The main question\[s\] it aims to answer are:

1. 1.Evaluate the PK of D3S-001 administered in the fasted and fed state in healthy adult participants.
2. 2.Evaluate the safety and tolerability of D3S-001 administered in the fasted and fed state in healthy adult participants.

Conditions

Healthy Adult Volunteers

Keywords

D3S-001; D3S-001-CP003; Phase 1; Effect of Food; Healthy Adult Participants

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Concentration (Cmax)

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

  From screening to end of treatment at 34 days

• Area under the concentration-time curve

  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.

  From screening to end of treatment at 34 days

Secondary Outcomes (8)

• 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)

• To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs.

  On screening day, Day -1 and Days 1-6 (End of Study)

• To determine the safety and tolerability of the drug in healthy subjects, as assessed by the collection of vital signs.

  On screening day, Day -1 and Days 1-6 (End of Study)

Study Arms (2)

Group 1 - Fasted and Fed

EXPERIMENTAL

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.

Drug: D3S-001

Group 2 - Fed and Fasted

EXPERIMENTAL

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.

Drug: D3S-001

Interventions

D3S-001 DRUG

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.

Group 1 - Fasted and Fed; Group 2 - Fed and Fasted

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• D3 Bio (Wuxi) Co., Ltd: lead
• Fortrea: collaborator

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Study Officials

• Thomas Polasek, MD

  CMAX Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a Phase 1, single-centre, open-label, randomised, crossover study in healthy adult male and female participants. Potential participants will be screened within 28 days prior to the first dose. Participants will be admitted into the clinical research unit (CRU) on Day -1 and will be confined until end of study (EOS) or until early termination. On Day 1, participants will be randomised to Group 1 or Group 2. Participants will receive Treatment A or Treatment B in each of 2 periods (Periods 1 and 2; Study Days 1 and 4), once under fasted conditions (Treatment A) and once under fed conditions (Treatment B).

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 30, 2025
• Study Start: July 11, 2025
• Primary Completion: November 12, 2025
• Study Completion: November 17, 2025
• Last Updated: March 25, 2026

Record last verified: 2025-09

Locations

AU (1)