I-Cali Biosciences Co., Ltd. imemezele imiphumela eyimpumelelo ocwaningweni lwayo lweSigaba IIb somkhiqizo wayo we-perioperative we-analgesic we-CPL-01, inguqulo yomjovo ekhishwa isikhathi eyengeziwe ye-Naropin® (ropivacaine hydrochloride), eyakhiwe yi-Cali Biosciences ukwelapha ngemva kokuhlinzwa. ubuhlungu bokuhlinzwa nokunciphisa isidingo sama-opioid.
Lesi sivivinyo somtholampilo seSigaba IIb saklanyelwe ukuqhubeka nokuphenya izinzuzo zomtholampilo ze-CPL-01 futhi siqhathanise nalezo zezidakamizwa ezikhona zokulawula ubuhlungu emakethe. Ukuhlolwa kwabonisa impendulo yomthamo omuhle kakhulu ekusebenzeni ngempumelelo. Kuthamo okuhleliwe njengamanje njengomthamo ozomakethwa, abantu abayi-14 abathole i-CPL-01 bakhombise i-AUC emaphakathi ngamahora angama-72 we-wWOCF elungiswe i-NRS-A (isiphetho esiyinhloko) esingu-286.8, okubonisa ukuthambekela kokubaluleka ezifundweni eziyi-13. abathole i-placebo (p=0.08) futhi abangcono kakhulu kunezifundo ezingama-40 ezithole i-Naropin®. Ukuba nenjongo komtholampilo kwaboniswa ngokubonisa umehluko wephoyinti le-AUC elingaphezu kwelilodwa ngehora.
Ukwengeza, ukusetshenziswa kwe-opioid ngamahora angu-72 ezifundweni ze-CPL-01 ezithole umthamo ozothengiswa kwehliswa phakathi uma kuqhathaniswa neqembu le-placebo noma iqembu le-Naropin® (okusho u-7.9 mg, ngokungafani no-15 mg we-placebo kanye 16 mg ye-Naropin®). Eqinisweni, cishe u-2/3 wezifundo ze-CPL-01 (9/14) ayengadingi nhlobo i-opioid ngemva kwamahora angu-72 okuqala ngemva kokuhlinzwa, uma kuqhathaniswa cishe nengxenye yezifundo ze-Naropin® kanye nama-30% e-placebo.
Kwakungekho okutholakele okunengqondo kokuphepha; okuwukuphela kokwelashwa kwavela izehlakalo ezimbi ezenzeke esihlokweni esingaphezu kwesisodwa se-CPL-01 kuwo wonke amaqoqo ngaphakathi kovivinyo (n=40) kwakuyisicanucanu, ukuhlanza, ukuqunjelwa, i-headache parasthesia, nesiyezi - zonke izenzakalo ezivame ukwenzeka ngemva kokuhlinzwa futhi ezingase zenzeke. ngemuva kokusetshenziswa kwe-opioid; akukho kulokhu obekucatshangwa ukuthi kuhlobene ne-CPL-01.
I-pharmacokinetics yomuthi iqhubeka nokusekela ukuphepha kwawo - isizathu esiyinhloko sokuthi i-ropivacaine esebenza isikhathi eside yenziwa, enezinzuzo ezingaba khona ngaphezu kwe-bupivacaine esebenza isikhathi eside etholakalayo njengamanje. Isilinganiso se-Cmax se-ropivacaine ezifundweni ezithole umthamo ongu-600 mg sasingu-978 ng/mL, siphansi kakhulu kunomkhawulo lapho ubuthi benhliziyo bubonakala khona (4000 ng/mL). I-CPL-01 ifinyelele ukugxila kwayo okuphezulu cishe emahoreni ayi-18 ngemuva kokuphathwa, ngokungafani ne-Naropin® (efinyelela kuyo phakathi nehora lokuqala ngemuva kokuphathwa).
LOKHO ONGAKUTHATHE KULESI SIHLOKO:
- Additionally, opioid use through 72 hours of the CPL-01 subjects who received the to-be marketed dose was cut in half compared to either the placebo group or the Naropin® group (mean of 7.
- In fact, approximately 2/3 of the CPL-01 subjects (9/14) required no opioids at all after the first 72 hours after the operation, compared to roughly half of the Naropin® subjects and 30% of the placebo ones.
- In the dose currently planned as the to-be marketed dose, 14 subjects who received CPL-01 showed a mean AUC through 72 hours of wWOCF adjusted NRS-A (the primary endpoint) of 286.
