TP03HN106 in Patients With Critical Limb Ischemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 18, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

December 30, 2025

Conditions
Critical Limb Ischemia
Interventions
DRUG

TP03HN106

"During the dose escalation phase, subjects will undergo a dose escalation trial of intravenous injection of TP03HN106 for 5 consecutive days to evaluate the safety and tolerance of the subjects to the injection dose of TP03HN106. The preset initial dose for this experiment is 10U/kg, with gradient doses of 20, 30, 40, and 50U/kg. Observe the subjects receiving the investigational drug for any adverse events (AEs) after daily intravenous injection.~During the maintenance treatment phase, the subjects will undergo two consecutive treatment courses at the final dose during the dose escalation phase. During each treatment course, subjects will complete the collection of efficacy and safety data for 14 consecutive days of medication (administered every 2 days) and 14 days of discontinuation to evaluate the efficacy and safety of TP03HN106 for subjects with critical limb ischemia."

Trial Locations (1)

215000

RECRUITING

The First Affiliated Hospital of Soochow University, Suzhou

All Listed Sponsors
collaborator

The First Affiliated Hospital of Soochow University

OTHER

lead

Talengen Institute of Life Sciences, Shenzhen, P.R. China.

OTHER