Open Label Clinical Trial of Intravenous Crotoxin Part 3
NCT01481532 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-04-15
Summary
The primary objective of the study is to assess whether human subjects can be made tolerant to intravenously administered Crotoxin and achieve higher and more therapeutically effective doses levels without the previously reported adverse effects associated with bolus i.m. administration.
Conditions
Interventions
- DRUG
-
Crotoxin
Intra patient dose escalation
Sponsors & Collaborators
-
Institut de Cancérologie de l'Ouest
collaborator UNKNOWN -
Celtic Biotech Ltd
lead INDUSTRY
Principal Investigators
-
Mario Campone, MD, Ph.D · INSTITUT DE CANCEROLOGIE DE L'QUEST, Saint Herblain, France
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-31
- Primary Completion
- 2027-10-31
- Completion
- 2027-11-30
Countries
- France
Study Locations
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