South Rampart Pharma has dosed the first patient in its Phase I multiple ascending dose (MAD) study of non-opioid investigational drug SRP-001 for relieving pain.
The MAD study is a continuation of a single ascending dose (SAD) study that enrolled a total of 40 patients.
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Patients initially received a dose of 300mg, with subsequent dose increases to 600mg, 900mg, and 2,000mg in the SAD study.
No serious adverse events or changes in laboratory values, including a robust PK profile, were observed.
In the MAD study of two cohorts, healthy male and female volunteers will receive SRP-001 orally.
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Cohort one will receive SRP-001 500mg once daily for five days while cohort two will be randomised into a 1:1 male-to-female ratio, including six active and two placebo groups.
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By GlobalDataSafety and tolerability are the primary endpoints. They will be determined using vital signs, laboratory safety tests, physical examinations, electrocardiograms, adverse events, and select PK/PD parameters.
Lotus Clinical Research chief scientific officer and founder Dr Neil Singla said: “SRP-001 has incredible promise as an efficacious NME analgesic that avoids the pernicious side effects of acetaminophen and NSAIDs.”
South Rampart Pharma plans to launch a Phase II proof-of-concept study once supportive data has been collected from the MAD study, which would assess SRP-001’s efficacy and safety in patients undergoing third molar extraction.
The trial will enrol 200 subjects in a double-blind, randomised, placebo- and comparator-controlled, multi-centre study.
For the earlier study designs for pain, South Rampart Pharma approached Lotus Clinical Research, which has expertise in designing pain studies in the US.
