Healthy Adult Volunteers
Conditions
Keywords
D3S-001, D3S-001-CP003, Phase 1, Effect of Food, Healthy Adult Participants
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. 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.
Interventions
DRUGD3S-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.
Sponsors
D3 Bio (Wuxi) Co., Ltd
Fortrea
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. |
| Number of clinically significant clinical laboratory findings | 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. |
| Number of clinically significant electrocardiogram parameters | 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. |
| 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) | Temperature in Degrees Celsius (℃) |
| Number of clinically significant physical examinations | 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. |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORThomas Polasek, MD
CMAX Clinical Research
Outcome results
None listed