What is the mechanism of action of this treatment?

The most common treatments studied in healthy subjects often focus on understanding the safety, tolerability, and pharmacokinetics of new drugs. For example, DF-003 is a potent inhibitor of alpha-kinase 1 (ALPK1), which plays a crucial role in immune and inflammatory responses. By inhibiting ALPK1, DF-003 can potentially reduce inflammation and fibrosis, making it a promising candidate for treating chronic kidney disease. Studying these mechanisms in healthy subjects is essential to ensure the drug's safety and proper metabolism before it is tested in patients with specific conditions.

What side effects are associated with this type of intervention?

In clinical trials involving healthy subjects, common side effects typically include mild to moderate gastrointestinal disturbances, headaches, fatigue, and localized reactions at the site of administration. Serious adverse effects are rare but can include hypersensitivity reactions and neurocognitive symptoms. These side effects are monitored through physical exams, vital signs, ECG changes, and laboratory tests.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments targeting alpha-kinase 1 (ALPK1) in healthy subjects. However, the FDA has approved various drugs for studying safety, tolerability, and pharmacokinetics in healthy subjects, particularly those targeting immune and inflammatory responses. These studies are crucial for establishing the preliminary safety profiles of new drugs before they are tested in patients with specific conditions. Examples include inhibitors of different kinases and immune modulators, which undergo rigorous testing in healthy volunteers to assess their potential therapeutic benefits and safety.

What other types of research exist?

Promising novel alternatives to DF-003 for healthy subjects considering treatment in 2024 include: 1) Ulixertinib (ERK1/2 inhibitor) which has shown early evidence of clinical activity in MAPK mutant advanced solid tumors, and 2) TAK-733 (MEK1/2 inhibitor) which has demonstrated antitumor effects in multiple cancer cell lines and xenograft models. Both drugs are in clinical trials and target pathways involved in inflammation and immune modulation.

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Small Molecule Inhibitor

DF-003 Safety and Tolerability Study in Healthy Subjects

Phase 1

Waitlist Available

Led By Javid Ghandehari, MD

Research Sponsored by Zhejiang Yao Yuan Biotechnology Ltd. (also known as Drug Farm)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 83 days

Summary

This trial is testing a new medicine, DF-003, in healthy people to check its safety and its effects on the body. DF-003 aims to reduce swelling and harm to the kidneys by stopping a protein that affects the immune system.

Who is the study for?

Healthy adults, aged 18-55, who are non-smokers or have quit smoking for at least 3 months. Women must be postmenopausal or surgically sterile; men should agree not to donate sperm and use contraception if necessary. Participants must have a stable heart rate and normal ECG readings, with no significant medical history that could affect the study.

What is being tested?

The trial is testing DF-003's safety and how it's processed by the body when taken orally in single/multiple doses by healthy people. It will also look into whether food affects its absorption. The drug targets an enzyme involved in immunity/inflammation and may help treat chronic kidney disease.

What are the potential side effects?

Participants will be monitored for side effects through physical exams, eye checks, vital sign measurements, ECGs, Holter monitoring, and lab tests. Specific side effects aren't listed but generally could include reactions at the drug administration site, gastrointestinal symptoms or changes in blood work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 83 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 83 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 83 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events (AEs)

Incidence of Serious Adverse Events (SAEs)

Secondary study objectives

Accumulation ratio (Rac) at Cmax for DF-003

Accumulation ratio area under the concentration-time curve for DF-003

Apparent plasma clearance of drug after extravascular administration (CL/F) for DF-003

+12 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: DF-003 (Single Ascending Dose, Part 1)Experimental Treatment1 Intervention

Participants will receive a single oral dose of 3 mg DF-003 (1 mg x 3).

Group II: DF-003 (Multiple Ascending Doses, Part 2)Experimental Treatment1 Intervention

Participants will receive DF-003 once daily by oral administration for 14 days. The specific doses given will be based on data collected in Part 1 of the study. This part of the study may include 1 mg, 5 mg, or 25 mg capsules.

Group III: Placebo (Single Ascending Dose, Part 1)Placebo Group1 Intervention

Visually matching 0 mg DF-003 capsules.

Group IV: Placebo (Multiple Ascending Doses, Part 2)Placebo Group1 Intervention

Visually matching 0 mg DF-003 capsules.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments studied in healthy subjects often focus on understanding the safety, tolerability, and pharmacokinetics of new drugs. For example, DF-003 is a potent inhibitor of alpha-kinase 1 (ALPK1), which plays a crucial role in immune and inflammatory responses. By inhibiting ALPK1, DF-003 can potentially reduce inflammation and fibrosis, making it a promising candidate for treating chronic kidney disease. Studying these mechanisms in healthy subjects is essential to ensure the drug's safety and proper metabolism before it is tested in patients with specific conditions.

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