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Phase-1 dose-escalation trial
Zelira’s final clinical report for a Phase 1 dose-escalation trial in chronic pain patients on long-term high-dose opioid treatment has demonstrated that the primary and secondary endpoints for safety and efficacy were met.
The study at St Vincent’s Hospital in Melbourne in conjunction with Emerald Clinics Ltd (ASX:EMD) in Perth, was conducted to assess the safety of Zelira's cannabis formulation (ZTL-103) in seven chronic pain patients already using high doses of opioids.
These patients all completed the study and were treated with a single sublingual dose of ZTL-103 containing 5 milligrams of total cannabinoids (2.5 milligrams THC and 2.5 milligrams CBD) on the first day.
After a seven-day washout, they received a 5-milligram dose at the same time as having a high-fat meal and continued to take two daily doses of 5 milligrams for seven days, before escalating to 20 milligrams per day for seven days, then up to 30 milligrams for a further seven days before taking a single dose of 25 milligrams.
The trial showed ZTL-103 is safe, with no serious adverse events reported, non-serious adverse events were mild and the maximal dose was generally well tolerated.