Safety and Efficacy of Oral Colostrum Derived Anti Influenza Antibodies in Healthy Volunteers

Hadassah Medical Center

Status and phase

Unknown

Phase 1

Conditions

Influenza

Treatments

Dietary Supplement: colostrum enriched with anti flu antibodies

Study type

Interventional

Funder types

Other

Identifiers

4811344-HMO-CTIL

Details and patient eligibility

About

Administration of colostrum enriched with anti-Flu antibodies may alter host's response to the flu virus.

Enrollment

10 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male volunteers ages 18-60
If participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication
Men > 18 years.
Ability and willingness of subject to provide informed consent
Screening tests' results within 15% of normal values

Exclusion criteria

Female
Continuous use of the following medications for more than 3 days within 30 days of study entry:
Immunosuppressives
Immune modulators
Systemic glucocorticoids
Anti-neoplastic agents
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry.
Subjects with a clinically significant infectious, immune mediated or malignant disease
Subjects with anemia (Hb <10.5 gm/dl)
Subjects with thrombocytopenia (platelets <100K/µl)
Subjects with lymphopenia (absolute lymphocyte count <0.7)
Subjects who were previously vaccinated against flu.
Subject who received any vaccination within the last 6 months