Trial reportScientific reports2025
An open-label phase I comparator-controlled clinical trial to assess tolerability and pharmacokinetics of IHL-675 A a fixed dose combination of cannabidiol plus hydroxychloroquine in healthy volunteers.
Trial report in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This was a phase I randomised comparator controlled clinical trial that assessed the pharmacokinetics (PK), and tolerability of IHL-675 A, a fixed dose combination (FDC) of cannabidiol (CBD) and hydroxychloroquine sulfate (HCQ), compared to the reference listed drugs Epidiolex (CBD) and Plaquenil (HCQ) in healthy volunteers (HVs). IHL-675 A is Incannex Healthcare Pty Ltd.'s proprietary product formulated using UniGel™ technology consisting of a solid, film coated HCQ tablet contained within a CBD-oil solution gel cap. Each IHL-675 A gel cap contains 75 mg of CBD and 100 mg HCQ. IHL-675 A is being developed for treatment of inflammatory conditions such as rheumatoid arthritis. This trial assessed the tolerability of IHL-675 A as well as pharmacokinetics of the active pharmaceutical ingredients CBD and HCQ as well as their major metabolites, compared to the reference listed drugs. The study included 3 treatment arms: IHL-675 A arm (150 mg CBD, 200 mg HCQ) and Plaquenil arm (200 mg HCQ) and Epidiolex (150 mg CBD) arm. Thirty-six participants were randomised into the 3 groups (12 per arm) and followed up for 4 weeks. Safety assessments including vital signs, electrocardiogram (ECG) parameters, and clinical laboratory parameters. Plasma concentrations of CBD, HCQ and their major metabolites, 7-OH-CBD, and 7-COOH-CBD, and desethylhydroxychloroquine (DHCQ), desethylchloroquine (DCQ), and bisdesethylhydroxy-chloroquine (BDCQ) were assessed at predefined timepoints across the monitoring period and PK parameters were determined and compared between treatments using noncompartmental methods and analysis of variance (ANOVA) of log-transformed values exposure PK parameters. All adverse events were coded using the current version of the Medical Dictionary for Regulatory Activities (MeDRA) by system organ class (SOC). IHL-675 A was generally well tolerated and had a similar adverse event profile compared to Epidiolex and Plaquenil. There were no SAEs reported in this study. Both CBD and HCQ were bioavailable when dosed in IHL-675 A. There were non-statistically significant differences between the pharmacokinetics of both CBD and HCQ when compared between IHL-675 A and Epidiolex or Plaquenil. There was approximately 50% increase in C
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