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

NCT07093398 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-03-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fortrea

    collaborator INDUSTRY

  • D3 Bio (Wuxi) Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Thomas Polasek, MD · CMAX Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2025-11-12
Completion
2025-11-17

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093398 on ClinicalTrials.gov