Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
(HFpEF Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants have stable doses of their current medications for at least 30 days before screening, meaning no new medications or significant changes in dosage. If you are on diuretics, you must be on a stable regimen that allows for flexible dosing.
What safety data exists for the treatment evaluated under names like HU6, Placebo, Control, and Dummy Treatment?
The safety reporting in clinical trials is often inadequate, with only a small percentage of trials providing detailed information on adverse effects and reasons for withdrawal due to toxicity. Placebos, often used in trials, are not always harmless as their contents are not always inert, which can affect safety data interpretation.12345
What makes the drug HU6 unique compared to other treatments?
The drug HU6 is unique because it is a synthetic cannabinoid that acts as a non-competitive NMDA receptor blocker, providing pain relief without the psychotropic effects typically associated with cannabinoids. This mechanism of action, combined with its ability to scavenge free radicals, makes it distinct from other treatments.678910
What is the purpose of this trial?
This trial tests a new drug called HU6 by giving participants increasing doses to find the safest and most effective amount. It involves individuals who meet specific health criteria.
Research Team
Shaharyar Khan, PhD
Principal Investigator
Rivus Pharmaceuticals, Inc.
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HU6 or placebo in a dose escalation manner: 150 mg daily for 20 days, followed by 300 mg daily for 20 days, and 450 mg daily for 94 days if safety and tolerability are demonstrated.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- HU6
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rivus Pharmaceuticals, Inc.
Lead Sponsor