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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 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.

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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Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Zhejiang Yao Yuan Biotechnology Ltd. (also known as Drug Farm)Lead Sponsor
Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Javid Ghandehari, MDPrincipal InvestigatorInterventional Pain Management Physician Anesthesiologist, Altasciences

Media Library

DF-003 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05997641 — Phase 1
Healthy Subjects Research Study Groups: DF-003 (Multiple Ascending Doses, Part 2), Placebo (Single Ascending Dose, Part 1), DF-003 (Single Ascending Dose, Part 1), Placebo (Multiple Ascending Doses, Part 2)
Healthy Subjects Clinical Trial 2023: DF-003 Highlights & Side Effects. Trial Name: NCT05997641 — Phase 1
DF-003 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05997641 — Phase 1
~48 spots leftby Oct 2025