A phase I clinical trial has found that a novel combination of cannabidiol (CBD) and hydroxychloroquine (HCQ), known as IHL-675 A, is well tolerated and bioavailable in healthy volunteers, supporting further investigation in inflammatory conditions such as rheumatoid arthritis.
The trial involved 36 participants who were randomly assigned to receive either IHL-675 A, Epidiolex (CBD), or Plaquenil (HCQ). IHL-675 A combines 75 mg of CBD and 100 mg of HCQ in a single gel capsule using UniGel technology. Participants were monitored over four weeks, with assessments of safety, tolerability, and pharmacokinetics (PK) of both active ingredients and their metabolites.
Adverse events (AEs) occurred in all treatment groups at similar rates, with 66.7% of participants in the IHL-675 A group reporting treatment-emergent AEs (TEAEs), compared to 58.3% for Epidiolex and 50% for Plaquenil. Most AEs were mild, with no severe or serious adverse events reported. Common AEs for IHL-675 A included headache, fatigue, and abdominal discomfort. Vital signs, ECGs, and laboratory tests showed no clinically significant abnormalities.
IHL-675 A was found to be generally well tolerated, with no serious adverse events reported. Its safety profile was similar to that of Epidiolex and Plaquenil. Although the combination product led to a roughly 50% increase in peak plasma concentration (Cmax) of CBD and a modest 10% increase in exposure (AUC), the pharmacokinetic differences were not statistically significant. For HCQ, the Cmax was nearly identical to that of Plaquenil, though there was a slight decrease in overall exposure.
For HCQ, absorption from IHL-675 A was slightly slower than from Plaquenil, likely due to the encapsulated tablet design. The Cmax of HCQ was similar across both treatments, while AUC was approximately 15% lower for IHL-675 A. Again, these differences were not statistically significant.
Researchers conclude the study by stating “These results support the continued clinical development of IHL-675 A.”
