Safety Study of Anti-Influenza Virus Monoclonal Antibody to Treat Influenza

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01390025
• Date of registration: 05/07/2011
• Primary sponsor: Theraclone Sciences, Inc.
• Public title: Safety Study of Anti-Influenza Virus Monoclonal Antibody to Treat Influenza
• Scientific title: Phase 1 Study of TCN-032 (Human Monoclonal Antibody Directed Against the M2 Protein of Influenza A Virus) in Healthy Adult Volunteers
• Date of first enrolment: September 2011
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01390025
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Mohamed Al-Ibrahim, MD, FACP
• Affiliation: SNBL

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy volunteers

- Normal lab tests

Exclusion Criteria:

- Prior treatment with a monoclonal antibody



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza, Human

Intervention(s)

Biological: Placebo

Biological: TCN-032

Primary Outcome(s)

Safety assessment - number of participants with adverse events (AE) [Time Frame: 60 days post infusion]

Secondary Outcome(s)

Immunogenicity - detect and measure generation of anti-drug antibodies (ADA)specific for TCN-032 [Time Frame: 60 days post infusion]

Pharmacokinetic analysis (PK)- Evaluate the single, ascending dose PK of TCN-032 [Time Frame: 60 days post infusion]

Secondary ID(s)

TCN-032-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors