PHA1A Clinical Trial
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
This study will evaluate the safety and tolerability of an intramuscular injection of SAB-176 intended for use as a pre/post 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 Sponsor's Clinical Monitor, and the Research Monitor prior to next cohort dose-escalation.
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 U.S. 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 and/or 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 U.S. 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 participant's 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. ;
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