Clearmind Medicine Inc. announced an agreement with IMP Clinical Supply Services.
IMP will be responsible for the global clinical supply chain of Clearmind’s proprietary drug candidate CMND-100 from manufacture to the various clinical sites. IMP is known for its comprehensive, tailor-made clinical supply services that address all study requirements. The array of services to be performed are fully compliant with GMP, GCP, and GDP standards. Clinical drug supply is a critical factor for trial success so collaboration with best-in-class clinical drug supply vendor forestalls the possibility of it being a bottleneck to successful drug delivery. Moreover, it can also deliver enormous benefits, including better investigator and patient experiences as well as cost savings in clinical drug supply.
The company's clinical trial is expected to commence in Q2 2023 in the United States and in Israel.
The primary end point of the trial is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated doses of CMND-100 in healthy subjects and those with Alcohol Use Disorder ("AUD").
The secondary end point is to preliminarily evaluate the efficacy of CMND-100 in reduction of drinking patterns and craving in individuals with moderate-to-severe AUD. Oral capsules will be administered once daily, for ten consecutive days. The patients will report their drinking patterns and craving for alcohol (and cigarettes) during the clinical trial period.
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