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Small Molecule Inhibitor

DF-003 Safety and Tolerability Study in Healthy Subjects

Phase 1
Recruiting
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
Awards & highlights

Study Summary

This trial evaluates the safety, tolerability, and drug metabolism of DF-003, a new drug being studied for its potential to treat chronic kidney disease. Up to 96 healthy volunteers will be monitored for adverse effects and data on physical/eye exams, ECGs, etc. will be collected.

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Secondary outcome measures
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.

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
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participating in this trial exceeding forty years of age?

"This medical research is enrolling individuals that are aged 18 and above, yet still under the age of 55."

Answered by AI

Is the participant recruitment for this experiment still ongoing?

"According to the information on clinicaltrials.gov, this investigation is presently recruiting participants. The project was inaugurated on August 31st 2023 and its most recent update came out of 8/9/2023."

Answered by AI

How hazardous is DF-003 (Single Ascending Dose, Part 1) for participants?

"Limited clinical data exists on the safety and efficacy of DF-003 (Single Ascending Dose, Part 1), thus it has been assessed as a level 1."

Answered by AI

What is the total capacity for volunteers in this trial?

"Affirmative. The clinicaltrials.gov portal indicates that this medical trial is actively enrolling participants with its original posting on August 31, 2023 and last edit on August 9th of the same year. A total of 96 patients must be enrolled at one location for completion."

Answered by AI

What criteria must individuals meet in order to be included in this trial?

"This clinical trial is seeking 96 volunteers that are in sound health and aged 18 to 55."

Answered by AI

What are the primary goals of this medical experiment?

"This clinical trial, with a maximum duration of 83 days, is designed to evaluate Serious Adverse Events (SAEs). Secondary objectives include assessing the pharmacokinetic parameters Time to Maximum Plasma Concentration (Tmax), Area Under the Curve from zero to time of last quantifiable concentration (AUC(0-t)), and AUC from zero to infinity (AUC(0-∞)) for DF-003."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Altasciences Clinical Los Angeles, Inc
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects
2023. "Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05997641.
~61 spots leftby May 2025
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