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.
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.
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.
Safety 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.