CTRI/2021/01/030587Recruiting未知
An open label study to investigate safety, tolerability and acceptability of needle free injection system in healthy volunteers in comparison to conventional needle-based system.
IntegriMedical0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •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
Investigators
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