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Completed

NCT Number: NCT07093398

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

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. Evaluate the PK of D3S-001 administered in the fasted and fed state in healthy adult participants. 2. Evaluate the safety and tolerability of D3S-001 administered in the fasted and fed state in healthy adult 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). Each participant will receive both treatments.

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Key information

Conditions

Healthy Adult Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

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.

Primary outcomes

  1. Maximum Observed Concentration (Cmax)

    Time frame: From screening to end of treatment at 34 days

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

  2. Area under the concentration-time curve

    Time frame: 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 outcomes

  1. Adverse events

    Time frame: From screening to end of study (approximately 34 days)

    Subjects will be observed for any signs or symptoms of adverse events and asked about their condition by open questioning, such as "How have you been feeling since you were last asked?", at least once each day while resident at the study site and at each study visit.

  2. Number of clinically significant clinical laboratory findings

    Time frame: On Screening visit, Day -1, Days 2-3 and Days 5-6 (End of Study)

    Evaluate the safety and tolerability of the drug through clinical laboratory assessments, including clinical chemistry, haematology, coagulation, and urinalysis.

  3. Number of clinically significant electrocardiogram parameters

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

    Evaluate the safety and tolerability of the drug using resting 12-lead electrocardiogram (ECG) parameters, recorded after the subject has been supine and at rest for at least 5 minutes. The following ECG Measurements will be recorded: Heart Rate, RR Interval, PR Internal, QRSD QT Interval, QTcB and QTcF.

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

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

    Temperature in Degrees Celsius (℃)

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

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

    Pulse in beats per minute (bpm)

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

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

    Respiratory Rate in respirations per minute (rpm)

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

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

    Systolic and Diastolic Blood Pressure in millimeters of mercury (mmHg)

  8. Number of clinically significant physical examinations

    Time frame: On Screening visit, Day -1 and Day 6 (End of Study)

    Evaluate the safety and tolerability of the drug by performing HEENT [head, eyes, ears, nose, and throat], mouth/dental, neck [including thyroid & nodes], cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin, and other examinations.

Sponsors and collaborators

Lead sponsor

D3 Bio (Wuxi) Co., Ltd

Industry

Collaborators

  • Fortrea

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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