Chemotherapy-induced Myelosuppression Clinical Trial
Official title:
A 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).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03692780 -
Careseng 1370 for Chemotherapy-Induced Myelosuppression
|
Phase 1/Phase 2 |