Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558643
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Single Ascending Dose Study to Assess the Safety Tolerability and Pharmacokinetics of MMV371 LAI in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-in-Human Single-Centre Single Ascending Dose Study to Assess the Safety Tolerability and Pharmacokinetics of a Single Intramuscular Injection of MMV371 Long-Acting Injection Formulation in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MV371 LAI FiH
Brief Summary:
This three-cohort first-in-human healthy participant study aims to assess the test medicines safety and tolerability including injection site reactions and how it is taken up by the body when given as a single dose
For Cohort 1 up to 8 participants will be randomly assigned to receive the starting dose of the test medicine or dummy medicine placebo as a single intramuscular injection
For Cohort 2 if the safety and tolerability results from Cohort 1 are satisfactory up to 8 participants will be randomly assigned to receive double the starting dose of the test medicine or dummy medicine placebo as a single intramuscular injection
For Cohort 3 if the safety and tolerability results from Cohort 1 are satisfactory up to 8 participants will be randomly assigned to receive double the Cohort 2 dose of the test medicine or dummy medicine placebo as a single intramuscular injection
Participants blood and urine will be taken throughout the study for analysis of the test medicine and for their safety When in the clinical unit the injection site will be checked daily for reactions and a diary will be provided on discharge for further recording Participants will be discharged 6 days after dosing and return to the clinical unit an additional 9 times for for safety assessments to be performed Participants are expected to be involved in this study for approximately 12 weeks for all study activities from screening to the final return visit
For Cohort 1 up to 8 participants will be randomly assigned to receive the starting dose of the test medicine or dummy medicine placebo as a single intramuscular injection
For Cohort 2 if the safety and tolerability results from Cohort 1 are satisfactory up to 8 participants will be randomly assigned to receive double the starting dose of the test medicine or dummy medicine placebo as a single intramuscular injection
For Cohort 3 if the safety and tolerability results from Cohort 1 are satisfactory up to 8 participants will be randomly assigned to receive double the Cohort 2 dose of the test medicine or dummy medicine placebo as a single intramuscular injection
Participants blood and urine will be taken throughout the study for analysis of the test medicine and for their safety When in the clinical unit the injection site will be checked daily for reactions and a diary will be provided on discharge for further recording Participants will be discharged 6 days after dosing and return to the clinical unit an additional 9 times for for safety assessments to be performed Participants are expected to be involved in this study for approximately 12 weeks for all study activities from screening to the final return visit
Detailed Description:
This is a single-centre participant- and investigator-blind randomised placebo-controlled single ascending dose SAD study to assess the safety tolerability and PK of a single intra-muscular depot injection of MMV371 long-acting injection LAI formulation in healthy participants
It is planned to enrol 3 sequential cohorts of up to 8 healthy male participants and healthy non-pregnant non-lactating female participants In each cohort participants will be randomised in a ratio of 6 active IMP to 2 placebo
All cohorts will follow a sentinel dosing design On Day 1 two sentinel participants sentinel group will be randomly assigned to receive a single IM dose of either active investigational medicinal product IMP or placebo 1 participant each to assess safety with a focus on acute severe toxicity and tolerability including injection site reactions ISRs
The sentinel group will be dosed concomitantly at least 48 h prior to the rest of the cohort main group The main group will comprise 6 participants randomly assigned to receive a single IM dose of either active IMP or placebo in a 51 ratio to assess safety and tolerability including ISRs
An interim data review of the safety tolerability including ISRs and PK data obtained up to Day 15 for each cohort will be conducted prior to the dose decision for the subsequent cohorts Should the data suggest that it is safe to proceed to the next dose group progression to that group will be permitted
The starting dose will be 112 mg MMV371 and dose escalation between SAD cohorts will be a maximum of 2-fold No dose selected will exceed 446 mg MMV371
Cohort 1 will receive Regime A MMV371 112 mg 05 mL or placebo
Cohort 2 will receive Regime B MMV371 223 mg 10 mL or placebo
Cohort 3 will receive Regime C MMV371 446 mg 20 mL or placebo
In each cohort participants will be dosed on Day 1 and will remain residents in the clinical unit until discharge on Day 6 They will be required to return to the clinical unit on Days 8 10 12 15 18 23 29 and Week 8 for the assessments detailed in the schedule of assessments and Week 12 for the end-of-study assessment
For all parts blood samples will be collected at regular intervals for PK analysis and safety from Day 1 to discharge from the study Participants will also be trained to complete an Injection Site Reaction DiaryISRD whilst resident in the clinical unit They will receive an ISRD at discharge on Day 6 and at each return visit until the EOS visit The ISRD should be completed at home to document new changing or re-appearing ISRs on non-visit daysweeks changes at the injection site or the re-appearance of an ISRs should be recorded in the diary whenever they occur
It is planned to enrol 3 sequential cohorts of up to 8 healthy male participants and healthy non-pregnant non-lactating female participants In each cohort participants will be randomised in a ratio of 6 active IMP to 2 placebo
All cohorts will follow a sentinel dosing design On Day 1 two sentinel participants sentinel group will be randomly assigned to receive a single IM dose of either active investigational medicinal product IMP or placebo 1 participant each to assess safety with a focus on acute severe toxicity and tolerability including injection site reactions ISRs
The sentinel group will be dosed concomitantly at least 48 h prior to the rest of the cohort main group The main group will comprise 6 participants randomly assigned to receive a single IM dose of either active IMP or placebo in a 51 ratio to assess safety and tolerability including ISRs
An interim data review of the safety tolerability including ISRs and PK data obtained up to Day 15 for each cohort will be conducted prior to the dose decision for the subsequent cohorts Should the data suggest that it is safe to proceed to the next dose group progression to that group will be permitted
The starting dose will be 112 mg MMV371 and dose escalation between SAD cohorts will be a maximum of 2-fold No dose selected will exceed 446 mg MMV371
Cohort 1 will receive Regime A MMV371 112 mg 05 mL or placebo
Cohort 2 will receive Regime B MMV371 223 mg 10 mL or placebo
Cohort 3 will receive Regime C MMV371 446 mg 20 mL or placebo
In each cohort participants will be dosed on Day 1 and will remain residents in the clinical unit until discharge on Day 6 They will be required to return to the clinical unit on Days 8 10 12 15 18 23 29 and Week 8 for the assessments detailed in the schedule of assessments and Week 12 for the end-of-study assessment
For all parts blood samples will be collected at regular intervals for PK analysis and safety from Day 1 to discharge from the study Participants will also be trained to complete an Injection Site Reaction DiaryISRD whilst resident in the clinical unit They will receive an ISRD at discharge on Day 6 and at each return visit until the EOS visit The ISRD should be completed at home to document new changing or re-appearing ISRs on non-visit daysweeks changes at the injection site or the re-appearance of an ISRs should be recorded in the diary whenever they occur
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None