Safety and treatment-emergent adverse events
nausea, diarrhea, abdominal pain, paresthesia, TEAEs, pain, dizziness, insomnia, musculoskeletal chest pain, headache, somnolence, deaths, dry mouth, TEAE
INJECTION SITE ERYTHEMA, ADVERSE EVENTS, EVENT, PARESTHESIA, INJECTION SITE SWELLING, INJECTION SITE REACTION, INFLUENZA-LIKE ILLNESS, INJECTION SITE REACTION, DRY MOUTH, INJECTION SITE HEMORRHAGE, VULVOVAGINAL CANDIDIASIS
No deaths, no serious adverse events, or significant adverse events leading to discontinuation of the study or study drug were reported (Summary of TEAEs by system organ class and preferred term (safety set)Subject will be counted only once in each category for more than 1 event.Subject can be represented more than once.N = total number of subjects in respective category.All TEAE were considered mild (n = 34) or moderate (n = 4) in severity; there were no serious TEAE. The majority of TEAE were definitely (9 subjects [42.9%], 15 TEAE), probably (2 subjects [9.5%], 2 TEAE), or possibly (7 subjects 33.3[%], 16 TEAE) related.In the MRG-001 0.005 mL/kg group (n = 4), two subjects (50.0%) reported six TEAE including diarrhea, dry mouth, injection site pain, and headache. In the MRG-001 0.01 mL/kg group (n = 5), three subjects (60.0%) reported five TEAE including diarrhea, nausea, injection site pain, and paresthesia. In the MRG-001 0.02 mL/kg group (n = 5), 5 subjects (100.0%) reported 26 TEAE, including abdominal pain, diarrhea, nausea, influenza-like illness, injection site erythema, injection site hemorrhage, injection site pain, injection site swelling, vulvovaginal candidiasis, musculoskeletal chest pain, dizziness, headache, somnolence, and insomnia.In the pooled placebo group (n = 7), one subject (14.3%) reported one mild, definitely related TEAE of injection site pain. Injection site reaction TEAE were noted in all three MRG-001 groups, with the MRG-001 0.02 mL/kg group having the greatest numbers. In the 0.005 mL/kg group, one subject had a mild TEAE of injection site pain that had a duration of 5 h. Two subjects in the 0.01 mL/kg group each had one mild TEAE of injection site pain with a duration of 10 min and 2 h 9 min. All five subjects in the 0.02 mL/kg group experienced injection site reaction TEAE. The most common injection site reaction TEAE was injection site pain (verbatim term: burning at the injection site) of mild (10 TEAE) or moderate (2 TEAE) intensity, with durations ranging from 15 min to 3 h. The only other injection site-related TEAE were reported in a single subject receiving MRG-001 0.02 mL/kg and included injection site erythema (mild), injection site swelling (mild), and injection site hemorrhage (moderate), all lasting approximately 1 day.There were no clinically significant abnormalities for chemistry, cardiac troponins, coagulation, or urinalysis parameters. The only significant abnormality, which had no clinical impact, was the increase of mean white blood cells (WBC) and its lineages in the peripheral circulation in subjects treated with MRG-001, as was expected. On average the WBC counts in test subjects increased 2- to 4-fold from baseline, while the placebo subjects did not show any increase.