None listed
Conditions
Interventions
Intervention1: MSP008-22: The SAD Part will consist of 5 cohorts of 8 healthy adult volunteers, each volunteer will be randomly (blinded) allocated to MSP008-22 or placebo (each cohort will consist of
Sponsors
Godavari Biorefineries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of participants with adverse events as a measure of safety and tolerability. [Time Frame- 30 days post last dose for each cohort 2.Incidence of serious adverse events (SAEs) by relation to the IMP (related/not related 3.Percentage of volunteers who experience at least 1 Treatment Emergent Adverse Event (TEAE) 4.Percentage of volunteers who discontinue due to an Adverse Event(AE). 5.Percentage of volunteers who meet the markedly abnormal criteria for safety laboratory tests at least once post dose (Grade 3 and above as per the most current version of the CTC AE). 6.Percentage of volunteers who meet the markedly abnormal criteria for vital sign measurements at least once post dose (Grade 3 and above as per the most current version of the CTC AE). 7.Percentage of volunteers who meet the markedly abnormal criteria for safety electrocardiogram (ECG) parameters at least once post doseTimepoint: 30 days post last dose | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetic profile of MSP008-22 in healthy adult volunteers, after single and multiple oral dosesTimepoint: Pharmacokinetics will be determined pre-dose 30 min, 1h, 2h, 4h, 8h, 12h, and 24, post-dose, and 36 hrs post-dose on Day 2 in the SAD Part.(Blood) Pharmacokinetics will be determined pre-dose 30 min, 1h, 2h, 4h, 8h, 12h, and 24h, of Day 1 and Day 7, pre-dose on Day 2-6 and 36 hrs post final dose of Day 7 in the MAD Part( (Blood). | — |
Countries
India
Contacts
Public ContactDr Sangeeta Srivastava
Clinexel Life Sciences Pvt Ltd
Outcome results
None listed