A Phase I Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of MSP008-22 in Healthy Adult Volunteers under Single Ascending Dose and Multiple Ascending Dose conditions.
- Registration Number
- CTRI/2022/08/045056
- Lead Sponsor
- Godavari Biorefineries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Should be healthy adult volunteer, with a BMI 18-30 kg/m2 (both inclusive).
2.Volunteer is able to read the volunteer information sheet, to understand information about the study and willing to sign the informed consent voluntarily.
3.Healthy as determined by pre-study medical history, physical examination, vital signs, haematology, chemistry parameters, pulse
rate and/or blood pressure, and ECG within the reference range, or showing no clinically relevant deviations, as judged by the Investigator.
4. Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis Cvirus antibody (anti-HCV) and human immunodeficiency virus(HIV)-l and HIV -2 antibody at screening.
5.Clinical laboratory test results clinically acceptable at screening and admission.
1.The volunteer has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests,as evaluated by the Investigator
2.The volunteer has had a clinically significant illness or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs, within 30 days of Check-in for the study.
3.The volunteer has a clinically relevant history or presence of significant respiratory, neurological, hepatic, renal, endocrine,
cardiovascular, neurological, gastrointestinal, pulmonary, haematological, psychiatric, musculoskeletal, genitourinary,
immunological, dermatological, endocrine, connective tissue,
lymphatic or metabolic disease or disorders.
4.The volunteer has a significant infection or known inflammatory process on screening or admission
5.The volunteer has acute gastrointestinal symptoms (e.g., nausea,
vomiting, diarrhoea, heartburn) at the time of screening or admission.
6.If female:
a. Pregnancy or breast-feeding.
b. Woman of childbearing potential not using an accepted effective contraceptive method or using oral contraceptives.
If male:
a. Not using an accepted effective method of contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method