| KM023 / Kainos Medicine |
ChiCTR1800019041: Phase 3 Efficacy and Safety Study of ACC007 Combined with 3TC+TDF in the Treatment of HIV/AIDS |
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| Completed | 3 | 630 | | Oral administration, once a day, ACC007 150mg + EFV placebo 1 tablet + 3TC 300mg + TDF 300mg. Blinding treatment period: Week 0 to Week 48; Open treatment period: Week 48 to Week 96 ;Oral administration, once a day, EFV 600mg + ACC007 placebo 1 tablet + 3TC 300mg + TDF 300mg. Blinding treatment period : Week 0 to Week 48; Open treatment period: Week 48 to Week 96 | Beijing You An Hospital, Capital Medical University; Jiangsu Aidea Pharmaceutical Co., Ltd, Self-financing | Non-nucleoside reverse transcriptase inhibitors,and other antiretroviral drugs in combination with HIV/AIDS | | | | |
ChiCTR2100051605: Randomized, Double-Blind, Double-Dummy, Phase III Study to Evaluate Switching From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors (NRTI) Plus a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI) to a Fixed Dose Combination(FDC) of ACC007 Versus Elvitegravir, in Virologically-Suppressed, HIV-1 Infected Participants&# |
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| Recruiting | 3 | 762 | | Tablet; Specification: Each tablet contains 150 mg of ACC007, 300 mg of lamivudine and 300 mg of tenofovir fumarate; it is orally administered on an empty stomach every day ;Tablet; Specification: Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 10mg of tenofovir alafenamide fumarate; it is orally administered with food every day | Beijing Ditan Hospital, Capital Medical University; Nanjing Accelas Pharmaceutical Co., Ltd. and Jiangsu Aidea Pharmaceutical Co., Ltd., self-funded | HIV/AIDS | | | | |
| Recruiting | 1 | 46 | | ACC007 tablets 75mg once a day ;ACC007 tablets 150mg once a day ;ACC007 tablets 300mg once a day ;Group A is administrated with single dose after fasting on Day 1 , and single dose after eating on Day 15. ;Group B is administrated with single dose after eating on Day 1 , and single dose after fasting on Day 15. | Beijing You An Hospital, Capital Medical University; Jiangsu Aidea Pharmaceutical.Co., Ltd., Self-financing | Non-nucleoside reverse transcriptase inhibitors, and other antiretroviral drugs in combination with HIV / AIDS. | | | | |
ChiCTR1800018007: Clinical Study of Drug- Drug Interaction between ACC007 and (3TC+TDF) |
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| Completed | 1 | 24 | | 300mg once a day oral administration of ACC007 tablets with 75mg specification, subjects in Group A are oral administrated with (3TC 300mg+TDF 300mg) from Day1 to Day17, and with the addition of 300mg ACC007 from Day8 to Day17 ;300mg once a day oral administration of ACC007 tablets with 75mg specification, subjects in Group B are oral administrated with 300mg ACC007 from Day1 to Day17, and with the addition of (3TC 300mg+TDF 300mg) from Day11 to Day17 | Beijing Di Tan Hospital, Capital Medical University; Jiangsu Aidea Pharmaceutical.Co., Ltd., Self-financing | Non-nucleoside reverse transcriptase inhibitors,and other antiretroviral drugs in combination with HIV/AIDS | | | | |
| Completed | 1 | 20 | | 150mg once a day oral administration of ACC007 tablets with 75mg specification for 10 consecutive days ;300mg once a day oral administration of ACC007 tablets with 75mg specification for 10 consecutive days | Beijing You An Hospital, Capital Medical University; Jiangsu Aidea Pharmaceutical Co., Ltd, Self-financing | Non-nucleoside reverse transcriptase inhibitors,and other antiretroviral drugs in combination with HIV/AIDS | | | | |
ChiCTR2000041558: A phase I Study on Absorption,Metabolism and Excretion of [14C] ACC007 in Chinese adult healthy volunteers (Human Material Balance and Biotransformation Research of [14C] ACC007) |
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| Recruiting | 1 | 6 | | Single oral suspension containing 150mg/100μCi [14C] ACC007 | The First Hospital Affiliated of Soochow University; Jiangsu Aidea Pharmaceutical Co., Ltd, Jiangsu Aidea Pharmaceutical Co.,Ltd | Chinese adult healthy volunteers | | | | |
| Completed | N/A | 48 | | Tablet; Specification: Each tablet contains 150 mg of ACC007, 300 mg of lamivudine and 300 mg of tenofovir fumarate; it is orally administered on an empty stomach, 1 tablet per cycle, 2 cycles in total. ;Tablet; Specification: ACC007 2 tablets + lamivudine 1 tablet + tenofovir fumarate 1 tablet; oral administration on an empty stomach, 2 tablets per cycle, 2 cycles in total. | Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School; Jiangsu Aidea Pharmaceutical Co., Ltd., Self-financing | HIV/ADIS | | | | |
| KM-819 / Kainos Medicine |
NCT05695378: Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy (MSA) |
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| Terminated | 2 | 68 | RoW | KM-819, Placebo | Kainos Medicine Inc., Parexel | Multiple System Atrophy | 08/24 | 08/24 | | |
NCT05670782: A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants With Parkinson's Disease |
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| Active, not recruiting | 2 | 314 | US | KM-819, Placebo | FAScinate Therapeutics Inc., Parexel | Parkinson Disease | 10/25 | 11/25 | | |
| Undisclosed COVID-19 therapeutic / Kainos Medicine |
| No trials found |
| Undisclosed HBV therapeutic / Kainos Medicine, Institut Pasteur Korea |
| No trials found |
| KM10544 / Kainos Medicine, Emmaus |
| No trials found |
