A Single Arm, Open Label, Single Dose and Multiple Dose Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects
Overview
- Phase
- Phase 1
- Intervention
- 101-PGC-005
- Conditions
- Glucocorticoids Toxicity
- Sponsor
- 101 Therapeutics
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Single dose PK
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- •History of allergy or hypersensitivity intolerance to Dexamethasone or its formulation excipients which, in the opinion of the clinical investigator, would compromise the safety of the subject or the study.
- •Has consumed dexamethasone or any other corticosteroid oral or intravenous for any reasons in past 4 weeks before study entry.
- •Hemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
- •Any medical or surgical conditions, which might significantly interfere with the normal functioning of the body or blood forming organs.
- •History of severe infection or major surgery in the past 6 months.
- •History of Minor surgery or fracture within the past 3 months.
- •Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction.
- •Any major illness or hospitalized within 90 days prior to check-in.
- •Any other clinical condition like diarrhea or vomiting within three days prior to dosing.
- •Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during the four weeks before screening.
Arms & Interventions
101-PGC-005 (Intervention arm)
Bolus Injection containing 30mg of 101-PGC-005 will administered intravenously once daily for 3 consecutive days
Intervention: 101-PGC-005
Outcomes
Primary Outcomes
Single dose PK
Time Frame: -0.5, 0.5, 0.75, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose
Quantification of 101-PGC-005 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- dosing with 101-PGC-005 injection on Day 1.
Multiple dose PK
Time Frame: -0.5, 0.5, 0.75, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose
Quantification of 101-PGC-005 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- dosing with 101-PGC-005 injection on Day 3.
Secondary Outcomes
- Evaluate free dexamethasone levels(-0.5, 0.5, 0.75, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose)
- Evaluate steroid induced hyperglycemia(5 days)