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.

NCT Number	NCT07093398
Lead Sponsor	D3 Bio (Wuxi) Co., Ltd Collaborators: Fortrea
Conditions	Healthy Adult Volunteers
Enrollment	26 participants
Start Date	2025-07-11
Primary Completion	2025-11-12 (estimated)
Study Completion	2025-11-17 (estimated)
Updated on ClinicalTrials.gov	2026-03-25