DF-003 Safety and Tolerability Study in Healthy Subjects

Overseen By Jeysen 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)

Must not be taking: Systemic contraceptives, Hormone therapy

Disqualifiers: Pregnancy, Renal dysfunction, Cardiovascular, others

Compensation: Varies

Number of Visits: 1

96 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

Who Is on the Research Team?

Javid Ghandehari, MD

Principal Investigator

Interventional Pain Management Physician Anesthesiologist, Altasciences

Are You a Good Fit for This Trial?

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)

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Visually matching 0 mg DF-003 capsules.

Group IV: Placebo (Multiple Ascending Doses, Part 2) Placebo Group 1 Intervention

Visually matching 0 mg DF-003 capsules.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benchmark dose-response analyses for multiple endpoints in drug safety evaluation. Vieira Silva, A., Ringblom, J., Moldeus, P., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Benchmark dose-response analyses for multiple endpoints in drug safety evaluation. [2021]

2. Italy pubmed.ncbi.nlm.nih.gov

Dexfentluramine in the treatment of juvenile obesity. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamics of the cathepsin S inhibitor, LY3000328, in healthy subjects. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Long-term changes of body weight and cardiovascular risk factors after weight reduction with group therapy and dexfenfluramine. [2014]

5. India pubmed.ncbi.nlm.nih.gov

Sub-chronic safety evaluation of ayurvedic immunostimulant formulation 'immuforte' in rats in reverse pharmacology. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical studies with d-fenfluramine. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Single-dose and steady-state pharmacokinetics of tenofovir disoproxil fumarate in human immunodeficiency virus-infected children. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Dexfenfluramine as an adjunct to a reduced-fat, ad libitum diet: effects on body composition, nutrient intake and cardiovascular risk factors. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment of Obese Patients with Dexfenfluramine: A Multicenter, Placebo-Controlled Study. [2019]