NCT07093398

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: D3 Bio (Wuxi) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adult Volunteers

Interventions

Type	Name	Description
DRUG	D3S-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.

Timeline

• Start date: 2025-07-11
• Primary completion: 2025-11-12
• Completion: 2025-11-17
• First posted: 2025-07-30
• Last updated: 2026-03-25

Locations

1 site across 1 country: Australia