To investigate safety, tolerability and acceptability of needle free injection system in healthy volunteers in comparison to conventional needle-based system.
- Registration Number
- CTRI/2021/01/030587
- Lead Sponsor
- IntegriMedical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Injection site reactions as assessed according to the toxicity scale provided by US FDA guidance with grading 0-4Timepoint: At Day 1
- Secondary Outcome Measures
Name Time Method Pain assessment using 100-mm VAS scores immediately after each administration (before needle removal)Timepoint: At Day 1