Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT05532293
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2022-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase One Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of MSP008-22 in Healthy Adult Volunteers
Sponsor:
Godavari Biorefineries Limited
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Clinical Study to Assess the Safety, Tolerability and Pharmacokinetics of MSP008-22 in Healthy Adult Volunteers
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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 5 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). Five (5) dose levels (200, 400, 400 (BD), 600(BD) and 900 (BD) mg) of the investigational medicinal product are selected for oral administration. An additional cohort of 8 volunteers (6:2 MSP008-22 vs placebo) 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 (600 (BD) and 900 (BD) mg) of the investigational medicinal product are selected for oral administration.
An additional cohort of 8 volunteers (6:2 MSP008-22 vs placebo) of lower doses (less than 900 mg BD) may be recruited into the MAD Part, if required.
Additional Volunteers will be enrolled to replace dropouts (volunteers withdrawing consent from the study for reasons other than safety). Additional volunteers will also be enrolled if a Cohort needs to be repeated.
Healthy adult volunteers eligible for participations in the study will be enrolled as study participants. They will be randomly assigned to the IMP (MSP008-22) and placebo arm of the SAD/MAD part.
A total Seventy Two (72) healthy adult volunteers volunteer (48 in the SAD part including additional cohort if required and 24 in MAD part including additional cohort if required).
Between each cohort, an interim analysis of PK, safety and tolerability will be performed. The available data will be evaluated by an independent Drug Safety Monitoring Board (DSMB). Once a dose level is judged to be safe, the DSMB will allow the escalation to the next cohort.
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.
DSMB will provide recommendations about stopping, modifying or continuing the study. Decision to escalate to next dose level/ Cohort, will be based on interim analysis of pharmacokinetic data, 36-hr post-dose, and 30-days post dose safety follow-up.
The dosing and the conduct of study between the cohorts will be staggered by approximately 2 to 4 weeks.
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
Pharmacokinetics will be determined at pre-dose, and 30 min, 1h, 2h, 4h, 8h, 12h, and 24, post-dose, and 36 hrs post-dose on Day 2, for the SAD Part of the Study.
Pharmacokinetics will be determined at pre-dose, and 30 min, 1h, 2h, 4h, 8h, 12h, and 24h, of Day 1 and Day 7, at pre-dose on Days 2-6 and 36 hrs post final dose of Day 7 for the MAD Part of the Study.
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 5 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). Five (5) dose levels (200, 400, 400 (BD), 600(BD) and 900 (BD) mg) of the investigational medicinal product are selected for oral administration. An additional cohort of 8 volunteers (6:2 MSP008-22 vs placebo) 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 (600 (BD) and 900 (BD) mg) of the investigational medicinal product are selected for oral administration.
An additional cohort of 8 volunteers (6:2 MSP008-22 vs placebo) of lower doses (less than 900 mg BD) may be recruited into the MAD Part, if required.
Additional Volunteers will be enrolled to replace dropouts (volunteers withdrawing consent from the study for reasons other than safety). Additional volunteers will also be enrolled if a Cohort needs to be repeated.
Healthy adult volunteers eligible for participations in the study will be enrolled as study participants. They will be randomly assigned to the IMP (MSP008-22) and placebo arm of the SAD/MAD part.
A total Seventy Two (72) healthy adult volunteers volunteer (48 in the SAD part including additional cohort if required and 24 in MAD part including additional cohort if required).
Between each cohort, an interim analysis of PK, safety and tolerability will be performed. The available data will be evaluated by an independent Drug Safety Monitoring Board (DSMB). Once a dose level is judged to be safe, the DSMB will allow the escalation to the next cohort.
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.
DSMB will provide recommendations about stopping, modifying or continuing the study. Decision to escalate to next dose level/ Cohort, will be based on interim analysis of pharmacokinetic data, 36-hr post-dose, and 30-days post dose safety follow-up.
The dosing and the conduct of study between the cohorts will be staggered by approximately 2 to 4 weeks.
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
Pharmacokinetics will be determined at pre-dose, and 30 min, 1h, 2h, 4h, 8h, 12h, and 24, post-dose, and 36 hrs post-dose on Day 2, for the SAD Part of the Study.
Pharmacokinetics will be determined at pre-dose, and 30 min, 1h, 2h, 4h, 8h, 12h, and 24h, of Day 1 and Day 7, at pre-dose on Days 2-6 and 36 hrs post final dose of Day 7 for the MAD Part of the Study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CTRI/2022/08/045056 | OTHER | Clinical Trials Registry-India | View |