Incannex Healthcare’s innovative fixed-dose combination, IHL-675 A, containing cannabidiol (CBD) and hydroxychloroquine sulfate (HCQ), has successfully completed a Phase I clinical trial. The study aimed to evaluate the safety and pharmacokinetic profiles of IHL-675 A compared to established treatments Epidiolex and Plaquenil in healthy volunteers.
The trial involved 36 participants randomly assigned to three groups: IHL-675 A, Plaquenil, and Epidiolex. Over a four-week period, researchers monitored vital signs, ECG parameters, and clinical laboratory results to assess tolerability and safety. Additionally, plasma levels of CBD, HCQ, and their metabolites were measured to understand the pharmacokinetics of the combination therapy.
Study Design and Participants
Participants were divided equally into three treatment arms, receiving either the combination drug IHL-675 A, Plaquenil alone, or Epidiolex alone. The dosage for IHL-675 A included 75 mg of CBD and 100 mg of HCQ per gel cap, administered alongside their respective formulations. The study employed noncompartmental methods and ANOVA for analyzing pharmacokinetic data, ensuring a robust comparison between the treatment groups.
Results and Pharmacokinetics
IHL-675 A was well-tolerated, exhibiting a safety profile comparable to Epidiolex and Plaquenil, with no serious adverse events reported. Pharmacokinetic analysis revealed that both CBD and HCQ were bioavailable in the combination therapy, showing a 50% increase in CBD’s peak concentration and a slight decrease in HCQ exposure. These variations remained within acceptable ranges, supporting the combination’s potential efficacy.
- IHL-675 A offers a balanced pharmacokinetic profile, enhancing CBD exposure while maintaining HCQ levels.
- The combination therapy did not introduce significant safety concerns compared to single-agent treatments.
The favorable tolerability and pharmacokinetic outcomes of IHL-675 A suggest it is a viable candidate for treating inflammatory conditions like rheumatoid arthritis. The increased CBD exposure may enhance therapeutic effects, while the stable HCQ levels ensure continued anti-inflammatory benefits.
Leveraging UniGela technology, IHL-675 A provides a novel delivery mechanism that may improve patient adherence and therapeutic outcomes. Its solid, film-coated HCQ tablet within a CBD-oil gel cap ensures consistent dosing and stability, potentially setting a new standard in combination therapy formulations.
Future studies should focus on the efficacy of IHL-675 A in patient populations with inflammatory diseases, exploring long-term safety and therapeutic benefits. Understanding the interaction between CBD and HCQ in diverse clinical settings will be crucial for optimizing treatment protocols and maximizing patient outcomes.
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