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NCT05997641 · ClinicalTrials.gov registry record · Phase 1
Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects
A Phase 1 study of Healthy and Safety and Tolerability, sponsored by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm).
- Active
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT05997641 is a Phase 1 study of Healthy and Safety and Tolerability that is active but no longer recruiting, run by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm). The registered enrollment target is 96 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05997641, a Phase 1 study of Healthy and Safety and Tolerability, is active but no longer recruiting, sponsored by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics (PK; drug metabolism) of DF-003 after oral administration of single and multiple ascending doses in healthy subjects. The choice of using healthy subjects is standard in establishing the preliminary safety and PK profile of a drug. DF-003 is a potent small molecule inhibitor of alpha-kinase 1 (ALPK1), which plays an important role in immunity and inflammation. DF-003 can inhibit the immune inflammatory response and has been shown to reduce renal fibrosis in preclinical models. Thus, this study aims to determine the role of DF-003 in the treatment of chronic kidney disease. This study will include 2 parts. Part 1 is a single ascending dose (SAD) phase with an optional food effect (FE) assessment, while Part 2 is a multiple ascending dose (MAD) phase. Part 1 - SAD Phase with optional FE assessment will include approximately 64 subjects (up to 8 cohorts of 8 subjects each) and Part 2 - MAD Phase will include approximately 32 subjects (up to 4 cohorts of 8 subjects each). Therefore, up to 96 subjects will be included in the study. Study participants will be screened approximately 42 days within the first scheduled administration of study medication. Screening data will be reviewed to determine subject eligibility. In Part 1, subjects will be randomly assigned to receive a single oral dose of DF-003 (3 x 1 milligram capsules) or matching placebo. The doses to be evaluated in Part 2 will be determined based on review of the available safety and PK data from Part 1. Subjects will be monitored for adverse events (AEs) and data will be collected for physical examination, eye examination, vital signs, 12-lead electrocardiogram (ECG), Holter monitoring, and clinical laboratory findings at various timepoints throughout the study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DF-003
Study Locations (1)
California
- Altasciences Clinical Los Angeles, Inc - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2023-09-15 |
| Est. Completion | 2025-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05997641
The ClinicalTrials.gov registry entry for NCT05997641 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (85% lower). The listed sponsor is Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm), which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05997641 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05997641 about?
NCT05997641 is a clinical study titled "Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects". The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics (PK; drug metabolism) of DF-003 after oral administration of single and multiple ascending doses in healthy subjects. The choice of using healthy subjects is standard in establishing the preliminary safety ...
What is the current status of trial NCT05997641?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2023-09-15. Estimated completion is 2025-01.
What conditions does trial NCT05997641 study?
This clinical trial studies the following conditions: Healthy, Safety and Tolerability.
What interventions are being tested in trial NCT05997641?
The interventions under investigation include: Placebo (DRUG), DF-003 (DRUG).
Who is sponsoring clinical trial NCT05997641?
This trial is sponsored by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm), which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05997641 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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