A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Melanoma
Interventions
BIOLOGICAL

Heat killed whole cell M. obuense (IMM-101) 0.1 mg

"Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.~Dose levels to be administered are 0.1 mg, 0.5 mg and 1.0 mg."

BIOLOGICAL

Heat-killed whole cell M.obuense (IMM-101) 0.5 mg

Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.

BIOLOGICAL

Heat killed whole cell M.obuense (IMM-101) 1.0 mg

Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.

Trial Locations (1)

W1G 8PZ

HCA Clinical Trials Unit, 79 Harley Street,, London

All Listed Sponsors
collaborator

HCA International Limited

OTHER

collaborator

Theradex

INDUSTRY

lead

Immodulon Therapeutics Ltd

INDUSTRY

NCT01308762 - A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients | Biotech Hunter | Biotech Hunter