96 Participants Needed

DF-003 Safety and Tolerability Study in Healthy Subjects

JY
Overseen ByJeysen Yogaratnam, MB.BCh, MRCSed, PhD, MBA
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Zhejiang Yao Yuan Biotechnology Ltd. (also known as Drug Farm)

Trial Summary

Will I have to stop taking my current medications?

Yes, participants must stop taking any prescription drugs 28 days before the study and over-the-counter medications 7 days before the study starts.

What safety data exists for DF-003 or similar treatments?

There is no specific safety data available for DF-003 in the provided research articles.12345

How is the drug DF-003 different from other treatments?

DF-003, also known as dexfenfluramine, is unique because it has been shown to help with weight loss by increasing adherence to diet and preventing weight regain, with few side effects. It has also been used to improve symptoms in conditions like premenstrual syndrome and seasonal affective disorder, which makes it different from other weight management drugs.46789

What is the purpose of this trial?

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.

Research Team

JG

Javid Ghandehari, MD

Principal Investigator

Interventional Pain Management Physician Anesthesiologist, Altasciences

Eligibility Criteria

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.

Inclusion Criteria

I am a healthy adult.
I follow the specified guidelines for contraception and procreation.
Provision of signed and dated informed consent form (ICF)
See 3 more

Exclusion Criteria

Presence of clinically significant ECG abnormalities
Positive test results for alcohol, drugs of abuse, or infectious diseases
I or my family have a history of skin diseases or immune disorders.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Single Ascending Dose (SAD) Phase

Participants receive a single oral dose of DF-003 or placebo to evaluate safety and pharmacokinetics

1 day
1 visit (in-person)

Multiple Ascending Dose (MAD) Phase

Participants receive multiple doses of DF-003 or placebo to evaluate safety and pharmacokinetics over 14 days

2 weeks
Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • DF-003
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials
1
Recruited
100+

Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)

Lead Sponsor

Trials
2
Recruited
110+

Findings from Research

The benchmark dose (BMD) modeling approach provides more detailed insights into dose-response relationships in drug development compared to the traditional no-observed-adverse-effect-level (NOAEL) method, allowing for better hazard characterization.
Using BMD modeling can reduce the need for animal testing by yielding more information from fewer animals and lower doses, making it a promising alternative or complement to the NOAEL approach in assessing potential drug toxicity.
Benchmark dose-response analyses for multiple endpoints in drug safety evaluation.Vieira Silva, A., Ringblom, J., Moldeus, P., et al.[2021]

References

Benchmark dose-response analyses for multiple endpoints in drug safety evaluation. [2021]
Dexfentluramine in the treatment of juvenile obesity. [2022]
Pharmacokinetics and pharmacodynamics of the cathepsin S inhibitor, LY3000328, in healthy subjects. [2021]
Long-term changes of body weight and cardiovascular risk factors after weight reduction with group therapy and dexfenfluramine. [2014]
Sub-chronic safety evaluation of ayurvedic immunostimulant formulation 'immuforte' in rats in reverse pharmacology. [2021]
Clinical studies with d-fenfluramine. [2018]
Single-dose and steady-state pharmacokinetics of tenofovir disoproxil fumarate in human immunodeficiency virus-infected children. [2021]
Dexfenfluramine as an adjunct to a reduced-fat, ad libitum diet: effects on body composition, nutrient intake and cardiovascular risk factors. [2014]
Treatment of Obese Patients with Dexfenfluramine: A Multicenter, Placebo-Controlled Study. [2019]
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