DF-003 Safety and Tolerability Study in Healthy Subjects
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD) Phase
Participants receive a single oral dose of DF-003 or placebo to evaluate safety and pharmacokinetics
Multiple Ascending Dose (MAD) Phase
Participants receive multiple doses of DF-003 or placebo to evaluate safety and pharmacokinetics over 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- DF-003
Find a Clinic Near You
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