Phase One Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of MSP008-22 in Healthy Adult Volunteers

This is a Phase I clinical study of MSP008-22, the Investigational Medicinal Product (IMP). The current study is designed to evaluate the safety and tolerability and pharmacokinetics of single and multiple oral doses of the IMP (MSP008-22) in healthy volunteers.

MSP008-22 is a New Chemical Entity (NCE) that has demonstrated positive outcomes during in vitro and in vivo studies for COVID19. This clinical study is planned as a double blind, randomised, placebo-controlled, combined clinical study of two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies, respectively. Pharmacokinetic (PK) profile of the MSP008-22 will also be assessed in both parts of the study. The safety, tolerability and pharmacokinetic data and results obtained from this study will determine the potentially efficacious doses of the IMP (MSP008-22) in the subsequent efficacy studies in COVID-19 patients. The SAD Part will consist of 6 cohorts of 8 healthy adult volunteers, each volunteer will be randomly (blinded) allocated to MSP008-22 or placebo (each cohort will consist of 6 volunteers receiving MSP008-22 and 2 volunteers receiving placebo). Six (6) dose levels (200 (OD), 400(OD), 400(BD), 600(BD), 800(BD) and 1000 (BD) mg) of MSP008-22 are selected for oral administration. An additional cohort of 8 volunteers (6:2 MSP008-22 vs placebo) of lower doses of MSP008-22 (less than 1000 mg BD) may be recruited into the SAD Part, if required. The MAD Part will consist of 2 cohorts of 8 healthy adult volunteers, each volunteer will be randomly (blinded) allocated to MSP008-22 or placebo (each cohort will consist of 6 volunteers receiving MSP008-22 and 2 volunteers receiving placebo). Two (2) dose levels (800(BD) and 1000(BD) mg) of the MSP008-22 are selected for oral administration. An additional cohort of 8 volunteers (6:2 MSP008-22 vs placebo) of lower doses of MSP008-22 (less than 1000 mg BD) may be recruited into the MAD Part, if required. Healthy adult volunteers eligible for participations in the study will be enrolled as study participants. They will be randomly assigned to the study drug (MSP008-22) and placebo arm during both the SAD and MAD parts of the study. A total of eighty (80) healthy adult volunteers volunteer (48 in the 06 cohorts of SAD part and 16 in the 02 cohorts of MAD part, and 16 subjects of the 02 additional cohorts in either SAD or MAD part of the study, if required) are planned to be enrolled and randomized in the study. Between each cohort, an interim analysis of PK, safety and tolerability will be performed. An independent Drug Safety Monitoring Board (DSMB) will provide recommendations about stopping, modifying or continuing the study. Decision to escalate to next higher dose level/ Ccohort will be based on interim analysis of pharmacokinetic data, safety data at 36-hr post-dose, as well as during the safety follow-up of 30-days post dose. Once a particular dose level is judged to be safe by the DSMB, the study will proceed and doses administered to the study subjects will escalate to the next higher dose level/ cohort. The dosing and the conduct of study between the cohorts will be staggered by approximately 2 to 4 weeks. Both the Investigator and study participants will remain blinded to the treatment administered (drug or placebo) till the final results of the study are obtained. Safety evaluation during both the SAD \& MAD pars of the clinical study will include adverse events, clinical laboratory/ pathological test results, electrocardiogram (ECG), and measurement of vital signs. Blood samples for pharmacokinetic profiling of MSP008-22 will be collected as follows: * for the first 04 dose cohorts of the SAD Part of the Study - at pre-dose (30 min prior to dosing), and at 1h, 2h, 4h, 8h, 12h, and 24h, and 36 h. * for the last 02 dose cohorts of the SAD Part of the Study - at pre-dose (30 min prior to dosing), and at 1h, 1.5h, 2h, 3h, 4h, 8h, 12h (pre dose for 2nd dose (approx. 02 mins prior to 2nd dose)), 14h, 16h, 18h, 24.00, and 36h. * for Day 1 of MAD part of the Study - at pre-dose (30 min prior to dosing), 1h, 1.5h, 2h, 3h, 4h, 8h, 12h (pre dose for 2ndpre dose (approx. 02 mins prior to 2nd dose)), 14h, 16h, 18h, and 24h (pre dose for 1st dose for Day 2 (approx. 02 mins prior to Day-2-1st dose)). * For Day 2 of MAD part of the Study - sample collected at 24h after Day 1-1st dose will be serve the purpose of pre-dose sample for Day 2 1st dose). * For Days 3 - 6 of MAD part of the Study - at pre-dose (30 mins prior to dosing of 1st dose/ morning dose). * for Day 7 of MAD part of the Study - at pre-dose (30 min prior to dosing), 1h, 1.5h, 2h, 3h, 4h, 8h, 12h (pre dose for 2nd dose (approx. 02 mins prior to 2nd dose)), 14h, 16h, 18h, 24h and 36h.