50
Participants
Start Date
October 6, 2020
Primary Completion Date
August 30, 2026
Study Completion Date
December 30, 2026
PTX-9908 Injection
"Proposed dose cohorts:1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, and 16 mg/kg.~Frequency:~Phase I: one dose per day for 4 consecutive weeks (20 doses). Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).~Duration: 4 weeks (Phase I) and 12 weeks (Phase II)."
Placebo
"water for injection~Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).~Duration: 12 weeks (Phase II)"
RECRUITING
National Taiwan University Hospital, New Taipei City
TCM Biotech International Corp.
INDUSTRY