Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human… (NCT05619770) | Clinical Trial Compass
UnknownPhase 1
Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects
India6 participantsStarted 2022-10-29
Plain-language summary
The goal of this interventional study is to evaluate the pharmacokinetics, safety, and tolerability of 101-PGC-005 in healthy, adult, human subjects. The main question it aims to answer is what are the single and multi-dose PK properties of 101-PGC-005 in the systemic circulation
Participants will receive a bolus injection of 101-PGC-005 administered intravenously once daily for 3 consecutive days. Blood and urine samples will be collected at predetermined timepoints for analysis.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Willing to provide audio-visual \& written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
* Willing to be available for the entire study period and to comply with protocol requirements. Should have reliable access to the clinical trial center and be available in the area for at least one month.
* Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
* Body mass index in the range of 18 -30 kg/m2 (both inclusive).
* Healthy volunteers who are clinically non-anemic will be included as per the discretion of PI/CI/Physician.
* Non-diabetic healthy adult with HbA1c \< 5.5 at the time of study entry
* Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.
* With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no. 9.1).
* With a normal or clinically non-significant 12-lead ECG.
* With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
* Non-smokers and should not have been consuming any kind of tobacco products including chewing or inhalin…