2
Clinical Trials associated with Careseng 1370A Phase I Dose-Escalation Study in Healthy Volunteers to Evaluate the Safety and Tolerability Profiles of Careseng 1370
This study will be performed in healthy volunteers in a conventional 3+3 dose-escalation design. Four cohorts (dose level A, B, C, and D) of up to 6 evaluable volunteers per cohort are planned to be sequentially accrued to receive Careseng 1370 1, 2, 3 and 4 sachets per day, 4,000 mg/sachet before meal (starting from 1 sachet). At least 5 days of staggering and with the investigator's judgement of no safety concern will be required to administer the next volunteer for the first three volunteers of each cohort. The staggering time is counted from Day 1 of one volunteer to Day 1 of the next volunteer.
Careseng 1370 should be taken around 1 hour before meal. No volunteer is allowed to be assigned to more than 1 dose level. All dose escalation/de-escalation decisions will be made by the Data and Safety Monitoring Board (DSMB).
A Phase I Dose-Finding Followed by Phase IIa Randomized, Double-Blind, Placebo-Controlled, Parallel, Add-on to Cisplatin Plus Docetaxel Study to Evaluate the Safety, Tolerability and Efficacy Profiles of Careseng 1370 to Treat Chemotherapy-Induced Myelosuppression in Advanced Non-Small Cell Lung Cancer (NSCLC) Subjects
This is a Phase I/IIa dose-finding (Phase I) followed by randomized, double-blind, placebo-controlled, parallel, add-on to cisplatin + docetaxel (Phase IIa) study to evaluate the safety, tolerability, and efficacy profiles of Careseng 1370 in subjects with advanced NSCLC.
100 Clinical Results associated with Careseng 1370
100 Translational Medicine associated with Careseng 1370
100 Patents (Medical) associated with Careseng 1370
100 Deals associated with Careseng 1370