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

D3 Bio (Wuxi)

Status and phase: Enrolling; Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Drug: D3S-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07093398

D3S-001-CP003

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Group 1 - Fasted and Fed

Experimental group

Description:

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.

Treatment:

Drug: D3S-001

Group 2 - Fed and Fasted

Experimental group

Description:

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:

Drug: D3S-001