A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

May 21, 2018

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2023

Conditions
Non-muscle Invasive Bladder Cancer
Interventions
DRUG

alpha1H, 7.4 mg/mL

Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)

OTHER

placebo

Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)

DRUG

alpha1H, 37 mg/mL

Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)

DRUG

alpha1H, 74 mg/mL

Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)

Trial Locations (1)

Unknown

RECRUITING

Motol University Hospital, Prague

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Hamlet Pharma AB

INDUSTRY