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Background: Though <i>Maytenus senegalensis</i> is one of the medicinal plants widely used in traditional medicine to treat infectious and inflammatory diseases in Africa, there is a lack of safety data regarding its use. Therefore, the study aimed to asselss the safety and tolerability of the antimalarial herbal remedy <i>M. senegalensis</i>. Material and Methods: The study design was an open-label, single-arm, dose-escalation. Twelve eligible male healthy Tanzanians aged 18 to 45 years were enrolled in four study dose groups. Volunteers’ safety and tolerability post-investigational-product administration were monitored on days 0 to 7,14, and 56. Results: There were no deaths or serious adverse events in any of the study groups, nor any adverse events that resulted in premature discontinuation. The significant mean changes observed in WBC (<i>p</i> = 0.003), Neutrophils (<i>p</i> = 0.02), Lymphocytes (<i>p</i> = 0.001), Eosinophils (<i>p</i> = 0.009), Alanine aminotransferase (<i>p</i> = 0.002), Creatinine (<i>p</i> = 0.03) and Total bilirubin (<i>p</i> = 0.004) laboratory parameters were not associated with any signs of toxicity or clinical symptoms. Conclusions: <i>M. senegalensis</i> was demonstrated to be safe and tolerable when administered at a dose of 800 mg every eight hours a day for four days. This study design may be adapted to evaluate other herbal remedies.