Healthy Clinical Trial - Evaluating the Safety, Tolerability, &

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05997641
Study type	Interventional
Source	Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	September 15, 2023
Completion date	January 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06052553` - A Study of TopSpin360 Training Device	N/A
Completed	`NCT05511077` - Biomarkers of Oat Product Intake: The BiOAT Marker Study	N/A
Recruiting	`NCT04632485` - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed	`NCT05931237` - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults	N/A
Terminated	`NCT04556032` - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women	N/A
Completed	`NCT04527718` - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers	Phase 1
Completed	`NCT04998695` - Health Effects of Consuming Olive Pomace Oil	N/A
Completed	`NCT04107441` - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects	Phase 1
Completed	`NCT04065295` - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225	Phase 1
Completed	`NCT01442831` - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects	Phase 1
Terminated	`NCT05934942` - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood	Phase 1
Recruiting	`NCT05525845` - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI	N/A
Completed	`NCT05515328` - A Study in Healthy Men to Test How BI 685509 is Processed in the Body	Phase 1
Completed	`NCT05030857` - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects	Phase 1
Completed	`NCT04967157` - Cognitive Effects of Citicoline on Attention in Healthy Men and Women	N/A
Recruiting	`NCT04494269` - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls	Phase 1
Recruiting	`NCT04714294` - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers	Phase 1
Completed	`NCT04539756` - Writing Activities and Emotions	N/A
Recruiting	`NCT04098510` - Concentration of MitoQ in Human Skeletal Muscle	N/A
Completed	`NCT03308110` - Bioavailability and Food Effect Study of Two Formulations of PF-06650833	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms