None listed
Conditions
Interventions
Intervention1: Needle Free Injection System: Needle Free Injection System is intended to deliver drugs and biologics through needle free injection sites. Typical doses range from 0.1 ml to 0.5 ml and
Sponsors
IntegriMedical
MrSarvesh R Mutha
Eligibility
Inclusion criteria
Inclusion criteria: Male or female in the age group 18 to 45 years both inclusive Able and willing to sign the informed consent form Physical examination without clinically significant findings Hemoglobin in the opinion of a PI as clinically not significant WBC and differential in the opinion of a PI as clinically not significant No history of liver disorders in past 3 months No history of kidney disorders in past 3 months No history of cardiovascular disorders in past 3 months No history of neurological disorders in past 3 months Negative human chorionic gonadotropin (beta-HCG) pregnancy test (urine) on day of enrollment In good general health without clinically significant medical history and based on clinical judgement of principal investigator
Exclusion criteria
Exclusion criteria: Breast-feeding women More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment Blood products within 16 weeks prior to enrollment Bleeding disorder history (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM, SC injection or blood draws Investigational research products within 4 weeks prior to enrollment or planning to receive investigational products while on the study Asthma that is not well controlled Diabetes mellitus (type I or II) Evidence of autoimmune disease or immunodeficiency Idiopathic urticaria within the past year Hypertension that is not well controlled Malignancy that is active or history of malignancy Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteerâ??s ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Injection site reactions as assessed according to the toxicity scale provided by US FDA guidance with grading 0-4Timepoint: At Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain assessment using 100-mm VAS scores immediately after each administration (before needle removal)Timepoint: At Day 1 | — |
Countries
India
Contacts
Public ContactMr Ankur Naik
IntegriMedical
Outcome results
None listed