Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607484
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Study Investigating the Safety Tolerability and Blood Concentration of the Substance SR-878
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single Ascending Dose Study to Assess the Safety Tolerability Pharmacokinetic and Pharmacodynamic Effects of SR-878 in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
SR-878 is a newly developed medicine that aims to treat autoimmune disorders It inhibits a protein iRhom2 that regulates enzymes that are involved in the production of cytokines small proteins that are crucial in controlling the activity of immune system cells This is the first study in humans and SR-878 will be administered once to each participant in 6 different doses to establish a safe dosage and investigate what are potential side effects
This clinical trial includes six study groups called cohorts and each cohort includes 8 participants In each cohort 6 participants will receive SR-878 and 2 participants will receive a placebo a dummy drug with no active ingredients that looks identical The comparison with placebo will be used to better assess the side effects of SR-878 The dose of SR-878 will be gradually increased between cohorts Participants in the first cohort will receive the lowest dose and if this is considered safe 10 days after dosing the next cohort will be initiated at a higher dose Participants visit the hospital regularly over the next 12 weeks after receiving SR-878 or placebo During these visits medical condition will be checked and blood will be taken
Participants in the third to sixth cohort will be injected with a product called LPS 24 hours after the infusion of the investigational product which may stimulate the immune system and cause a temporary inflammatory response in the body During this time participants may have mild flu-like symptoms 12 weeks after dose of investigational product the LPS injection and saline infusion will be repeated
This clinical trial includes six study groups called cohorts and each cohort includes 8 participants In each cohort 6 participants will receive SR-878 and 2 participants will receive a placebo a dummy drug with no active ingredients that looks identical The comparison with placebo will be used to better assess the side effects of SR-878 The dose of SR-878 will be gradually increased between cohorts Participants in the first cohort will receive the lowest dose and if this is considered safe 10 days after dosing the next cohort will be initiated at a higher dose Participants visit the hospital regularly over the next 12 weeks after receiving SR-878 or placebo During these visits medical condition will be checked and blood will be taken
Participants in the third to sixth cohort will be injected with a product called LPS 24 hours after the infusion of the investigational product which may stimulate the immune system and cause a temporary inflammatory response in the body During this time participants may have mild flu-like symptoms 12 weeks after dose of investigational product the LPS injection and saline infusion will be repeated
Detailed Description:
Rationale SR-878 is a newly developed medicine that aims to treat autoimmune disorders It works by blocking a protein called iRhom2 which controls the production of small proteins called cytokines Cytokines are the drivers that keep the inflammatory process ongoing in autoimmune diseases important for regulating the activity of cells in the immune system This is the first study in humans and SR-878 will be administered once to each participant in 6 different doses to investigate potential side effects
Objectives
To assess the safety and tolerability of a single dose of SR-878
To select the optimal dose that is safe and tolerable
To explore any effects of a single dose of SR-878 in the human body
To investigate the connection between the concentration of SR-878 and potential side effects
To assess the amount of immune response against SR-878 Trial design This clinical study will have six treatment groups so called cohorts and each cohort will include 8 participants In each cohort 6 participants will receive SR-878 and 2 participants will receive a placebo that is a dummy treatment without active ingredients The comparison with the placebo is used to better assess the side effects of SR-878 The dose of SR-878 will be gradually increased between cohorts
After the screening period participants will be randomly assigned to receive SR-878 or placebo This is a double-blind study which means neither the participant nor the study staff including the study doctor will know which study medication was used
The study medication will be administered in a 1-hour long infusion The participants will be requested to stay 24 hours in the hospital after the infusion and their medical condition will be monitored and they will undergo several blood draws
24 hours after the study medication infusion participants in the 3rd-6th cohorts will be injected with a product called lipopolysaccharide LPS It has the ability to boost the bodys immune response even without causing an actual infection LPS might trigger slight flu-like symptoms ie uneasiness little fever Participants will be requested to stay an additional 8 hours in the hospital and they will undergo several blood samplings and their bodys reaction will be monitored In the first 6 hours they will receive a saline infusion to keep them hydrated and in case they find the potential symptoms of the provoked inflammation unbearable the study doctor will provide a medication paracetamol to relieve them
In the following 12 weeks participants will be requested to return regularly to the hospital 10 times in total During these visits their medical status will be examined and blood will be collected For participants in the 3rd-6th cohorts 12 weeks after their study medication dose the LPS injection and the saline infusion will be repeated and they will stay 8 hours again on the site They will undergo several blood draws and their medical condition will be monitored They will also be requested to return to the site on the next day to repeat these assessments
Interventions
Participants will receive SR-878 in a 1-hour long infusion once The dose will depend on the cohort
Participants in the 3rd-6th cohorts will receive LPS injections twice in a dose of 2 ngkg body weight
Objectives
To assess the safety and tolerability of a single dose of SR-878
To select the optimal dose that is safe and tolerable
To explore any effects of a single dose of SR-878 in the human body
To investigate the connection between the concentration of SR-878 and potential side effects
To assess the amount of immune response against SR-878 Trial design This clinical study will have six treatment groups so called cohorts and each cohort will include 8 participants In each cohort 6 participants will receive SR-878 and 2 participants will receive a placebo that is a dummy treatment without active ingredients The comparison with the placebo is used to better assess the side effects of SR-878 The dose of SR-878 will be gradually increased between cohorts
After the screening period participants will be randomly assigned to receive SR-878 or placebo This is a double-blind study which means neither the participant nor the study staff including the study doctor will know which study medication was used
The study medication will be administered in a 1-hour long infusion The participants will be requested to stay 24 hours in the hospital after the infusion and their medical condition will be monitored and they will undergo several blood draws
24 hours after the study medication infusion participants in the 3rd-6th cohorts will be injected with a product called lipopolysaccharide LPS It has the ability to boost the bodys immune response even without causing an actual infection LPS might trigger slight flu-like symptoms ie uneasiness little fever Participants will be requested to stay an additional 8 hours in the hospital and they will undergo several blood samplings and their bodys reaction will be monitored In the first 6 hours they will receive a saline infusion to keep them hydrated and in case they find the potential symptoms of the provoked inflammation unbearable the study doctor will provide a medication paracetamol to relieve them
In the following 12 weeks participants will be requested to return regularly to the hospital 10 times in total During these visits their medical status will be examined and blood will be collected For participants in the 3rd-6th cohorts 12 weeks after their study medication dose the LPS injection and the saline infusion will be repeated and they will stay 8 hours again on the site They will undergo several blood draws and their medical condition will be monitored They will also be requested to return to the site on the next day to repeat these assessments
Interventions
Participants will receive SR-878 in a 1-hour long infusion once The dose will depend on the cohort
Participants in the 3rd-6th cohorts will receive LPS injections twice in a dose of 2 ngkg body weight
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