Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435936
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-14
Brief Title:
A Study to Assess the Safety of SAB-176 to Prevent the Flu Given IM in Healthy Adults Compared With Placebo
Sponsor:
SAb Biotherapeutics Inc
Organization:
SAb Biotherapeutics Inc
Study Overview
Official Title:
A Phase 1 Double-Blinded Randomized Placebo-Controlled Study Assessing Safety and Pharmacokinetics of Intramuscular SAB-176 a Tc Bovine Derived Anti-Influenza Human Immunoglobulin in Healthy Subjects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
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:
SAB-176-103
Brief Summary:
This study will evaluate the safety and tolerability of an intramuscular injection of SAB-176 intended for use as a prepost prophylactic for influenza
This is a Phase 1 randomized double-blind placebo-controlled clinical trial in which a total of 28 subjects will receive an injection of either SAB-176 or placebo normal saline The investigational product will be administered intramuscularly IM on Day 1 Four dose escalation cohorts of 7 subjects 5 active and 2 placebo each are planned Subjects will be randomized to receive either SAB-176 or placebo in a double-blinded manner
Progression to subsequent dose-escalating cohorts will be dependent on safety measured through Day 5 after dosing of the previous cohort
Blood specimens will be collected at prescribed intervals to examine pharmacokinetics and immunogenicity Safety will be actively monitored during investigational product administration and for 60 days following dosing The decision to advance to the next cohort will be based solely on the safety assessment through Day 5 All safety data will be summarized and reviewed by the PI the Sponsors Clinical Monitor and the Research Monitor prior to next cohort dose-escalation
This is a Phase 1 randomized double-blind placebo-controlled clinical trial in which a total of 28 subjects will receive an injection of either SAB-176 or placebo normal saline The investigational product will be administered intramuscularly IM on Day 1 Four dose escalation cohorts of 7 subjects 5 active and 2 placebo each are planned Subjects will be randomized to receive either SAB-176 or placebo in a double-blinded manner
Progression to subsequent dose-escalating cohorts will be dependent on safety measured through Day 5 after dosing of the previous cohort
Blood specimens will be collected at prescribed intervals to examine pharmacokinetics and immunogenicity Safety will be actively monitored during investigational product administration and for 60 days following dosing The decision to advance to the next cohort will be based solely on the safety assessment through Day 5 All safety data will be summarized and reviewed by the PI the Sponsors Clinical Monitor and the Research Monitor prior to next cohort dose-escalation
Detailed Description:
The purpose of this study is to assess the safety of an experimental product for influenza Influenza commonly known as the flu causes substantial illness and death worldwide despite available treatments and vaccines The US military is susceptible to large outbreaks from new strains of influenza and effective treatment options can be limited Importantly the DoD deploys people all over the world Flu treatment may be more limited overseas Thus the military is trying to develop new products to treat and prevent influenza
The experimental product being testing in this study is called SAB-176 It was developed by SAB Biotherapeutics Inc SAB-176 is an immunoglobulin product designed to prevent the flu andor reduce its symptoms Immunoglobulins are antibodies disease fighting substances made by the immune system that can prevent and treat infections SAB-176 comes from the plasma the light yellow liquid part of blood of immunized cows Antibodies in the plasma are collected and purified Those purified antibodies are SAB-176
This study will assess the safety of the experimental study product SAB-176 in healthy adults SAB-176 is not approved by the US Food and Drug Administration FDA yet and is investigational The FDA is aware of this trial though and this research is required before SAB- 176 can be approved SAB-176 will be given by intramuscular injection a shot into the muscle The study is designed to find out if it is safe to give increasing doses of SAB-176 The investigators will look for any side effects The study will also assess the amount of SAB-176 circulating in participants bloodstream The investigators want to find a safe dose of SAB-176 that also enables SAB-176 to circulate in the blood for a longer time The investigators think this will provide longer lasting protection against the flu Some participants will be given a placebo instead of SAB-176 The placebo contains normal saline salt water The placebo does not contain any of the active ingredients of SAB-176 The investigator and sponsor will compare the side effects of those who got the placebo to those who got SAB-176 This helps to know which side effects are caused by SAB-176 Neither Participants nor the study staff will know what Participants are getting until after the study is complete Participants will be assigned to receive either SAB-176 or the placebo randomly like rolling dice
Participants will be in the study for about 3 months Participants will need to attend a screening visit to determine if Participants are eligible to participate If Participants are eligible and Participants agree to join the study Participants will remain in the study for 2 months after Participants receive SAB-176 or placebo to monitor any side effects
The experimental product being testing in this study is called SAB-176 It was developed by SAB Biotherapeutics Inc SAB-176 is an immunoglobulin product designed to prevent the flu andor reduce its symptoms Immunoglobulins are antibodies disease fighting substances made by the immune system that can prevent and treat infections SAB-176 comes from the plasma the light yellow liquid part of blood of immunized cows Antibodies in the plasma are collected and purified Those purified antibodies are SAB-176
This study will assess the safety of the experimental study product SAB-176 in healthy adults SAB-176 is not approved by the US Food and Drug Administration FDA yet and is investigational The FDA is aware of this trial though and this research is required before SAB- 176 can be approved SAB-176 will be given by intramuscular injection a shot into the muscle The study is designed to find out if it is safe to give increasing doses of SAB-176 The investigators will look for any side effects The study will also assess the amount of SAB-176 circulating in participants bloodstream The investigators want to find a safe dose of SAB-176 that also enables SAB-176 to circulate in the blood for a longer time The investigators think this will provide longer lasting protection against the flu Some participants will be given a placebo instead of SAB-176 The placebo contains normal saline salt water The placebo does not contain any of the active ingredients of SAB-176 The investigator and sponsor will compare the side effects of those who got the placebo to those who got SAB-176 This helps to know which side effects are caused by SAB-176 Neither Participants nor the study staff will know what Participants are getting until after the study is complete Participants will be assigned to receive either SAB-176 or the placebo randomly like rolling dice
Participants will be in the study for about 3 months Participants will need to attend a screening visit to determine if Participants are eligible to participate If Participants are eligible and Participants agree to join the study Participants will remain in the study for 2 months after Participants receive SAB-176 or placebo to monitor any side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None