PHA1APhase 1SAB-176-103NCT06435936
A Study to Assess the Safety of SAB-176 to Prevent the Flu, Given IM in Healthy Adults Compared With Placebo
A Phase 1 study testing Single Ascending Dose of SAB-176 in people with PHA1A, run by SAb Biotherapeutics, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- PHA1A
- What is being tested?
- Single Ascending Dose of SAB-176
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 1 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy adult, male or female, aged 18 to 60 years (inclusive) at the time of enrollment.
- 2. Completion and review of assessment of understanding test (achieved > 70% accuracy).
- 3. Signed informed consent document. 4. Available for the required follow-up period and scheduled clinic visits. 5. Women of childbearing potential: Negative urine pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within two (2) months following investigational product administration.
- 6. Willing to use an acceptable method of contraception during the study and for 2 months following investigational product administration. If a barrier method is the contraceptive of choice, concurrent use of a spermicide will be recommended.
- 7. Body mass index (BMI) between 19 and 35 kg/m2. 8. Agree to refrain from blood donation during the study and for at least 12 months (1 year) following injection with the study drug.
Who cannot join
- 1. Health problems (for example, intercurrent febrile illness, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension, or any other condition that might place the subject at increased risk of adverse events); study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion.
- 2. Clinically significant abnormalities on physical examination that, in the PI's opinion, would place the subject at undue risk and/or preclude full evaluation of potential adverse events.
- 3. Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or inherited or acquired immunodeficiency (including IgA deficiency; defined by serum IgA <7 mg/dL).
- 4. Women who are pregnant or planning to become pregnant during the study period plus 2 months beyond the last received dose, and currently nursing women.
- 5. History of buttock enhancement (e.g., silicone enhancement or implants) that may interfere with intramuscular injections.
- 6. Participation in research involving another investigational product (defined as receipt of an investigational product such as a drug or vaccine or exposure to an invasive investigational device) within 30 days prior to dosing or any time through the last study safety visit.
Show all 16Show fewer
- 7. Receipt of any unapproved immunizations or vaccines within 30 days prior to planned dosing.
- 8. Positive blood test for HBsAg, HCV, or HIV-1/2. 9. Clinically significant abnormalities on basic laboratory screening. 10. Moderate or severe influenza requiring hospitalization in the 30 days prior to planned dosing.
- 11. Receipt of any blood product (e.g., RhoGam, IVIG) within 120 days prior to planned dosing.
- 12. Use of other drugs that, in the opinion of the investigator, could complicate the safety assessment of SAB-176 (e.g., medications or over-the-counter vitamins or supplements formulated in bovine gelatin).
- 13. Vaccination against influenza less than 90 days prior to product administration.
- 14. Known autoimmune condition requiring therapy more intensive than intermittent nonsteroidal anti-inflammatories in the 6 months prior to planned dosing (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease).
- 15. Chronic respiratory disease including chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, pulmonary hypertension, or other chronic condition that requires the routine use of supplemental oxygen.
- 16. Chronic asthma requiring the use of oral steroids or hospitalization in the last six months; inhaled steroids are permitted.
- 17. Receipt of pooled immunoglobulin or plasma within 30 days prior to planned dosing.
- 18. History of allergy, anaphylaxis, or severe reaction to beef products (including dairy products and gelatin).
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Research Command (NMRC)
Bethesda, Maryland, 20889
About this study
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.
Read more
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.
Read the 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 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.
- Conditions
- PHA1A
- Being tested
- Single Ascending Dose of SAB-176, Single Ascending Dose of Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Ascending Dose of SAB-176Drug
Also called SAB-176
Single ascending dose
Single Ascending Dose of PlaceboDrug
Also called Placebo
Single ascending dose
| Study group | Role | What they receive |
|---|---|---|
| SAB-176 1 mL | Experimental | 1 mL (~75 mg) SAB-176 dose Receives: Drug: Single Ascending Dose of SAB-176 |
| Placebo 1mL | Placebo comparator | Normal Saline Receives: Drug: Single Ascending Dose of Placebo |
| SAB-176 3mL | Experimental | 3 mL (~225 mg) SAB-176 dose Receives: Drug: Single Ascending Dose of SAB-176 |
| Placebo 3mL | Placebo comparator | Normal Saline Receives: Drug: Single Ascending Dose of Placebo |
| SAB-176 5mL | Experimental | 5 mL (~375 mg) SAB-176 dose Receives: Drug: Single Ascending Dose of SAB-176 |
| Placebo 5mL | Placebo comparator | Normal Saline Receives: Drug: Single Ascending Dose of Placebo |
| SAB-176 20mL | Experimental | 20 mL (~1500 mg) SAB-176 dose Receives: Drug: Single Ascending Dose of SAB-176 |
| Placebo 20mL | Placebo comparator | Normal Saline Receives: Drug: Single Ascending Dose of Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited local and systemic adverse events (AEs) through Day 29.
Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
Measured: Dosing through Day 29
Occurrence of IP-related unsolicited AEs through Day 61.
Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
Measured: Dosing through Day 61
Occurrence of serious adverse events (SAEs) through Day 61.
Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
Measured: Dosing through Day 61
Secondary outcomes (9)
Hemagglutination Inhibition (HAI) against influenza A strains (H1N1, H3N2)
The pharmacokinetic profile will be assessed based on hemagglutination inhibition against multiple influenza A strains (H1N1, H3N2).
Measured: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Microneutralization (MN) titers against influenza A strains (H1N1, H3N2)
The pharmacokinetic profile will be assessed based on microneutralization against multiple influenza A strains (H1N1, H3N2).
Measured: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Hemagglutination Inhibition (HAI) against influenza B strains (B-Victoria lineage, B/Yamagata lineage)
The pharmacokinetic profile will be assessed based on hemagglutination inhibition against influenza B strains (B-Victoria lineage, B/Yamagata lineage).
Measured: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Microneutralization (MN) titers against influenza B strains (B-Victoria lineage, B/Yamagata lineage)
The pharmacokinetic profile will be assessed based on microneutralization against influenza B strains (B-Victoria lineage, B/Yamagata lineage).
Measured: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Maximum titer value (Cmax)
The pharmacokinetic profile will be assessed using the following parameter: maximum titer value (Cmax)
Measured: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Time of maximum titer value (Tmax)
The pharmacokinetic profile will be assessed using the following parameter: time of maximum titer value (Tmax)
Measured: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Terminal phase elimination rate constant (λZ)
The pharmacokinetic profile will be assessed using the following parameter: terminal phase elimination rate constant (λZ)
Measured: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Terminal elimination half-life (t½)
The pharmacokinetic profile will be assessed using the following parameter: terminal elimination half-life (t½).
Measured: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Area under the curve (AUC)
The pharmacokinetic profile will be assessed using the following parameter: area under the curve (AUC).
Measured: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start22 Apr 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PHA1AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- SAb Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nehkonti Adams, MD, Principal investigator, Naval Medical Research Command (NMRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435936
- Sponsor's protocol ID
- SAB-176-103
- Acronym
- SAB-176-103
- Status last verified
- Sep 2024
- First submitted
- 14 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06435936
- Acronym / sponsor ID
- SAB-176-103 / SAB-176-103
- Conditions
- PHA1A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SAb Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SAB-176 1 mL | Experimental | Drug: Single Ascending Dose of SAB-1761 mL (~75 mg) SAB-176 dose |
| Placebo 1mL | Placebo comparator | Drug: Single Ascending Dose of PlaceboNormal Saline |
| SAB-176 3mL | Experimental | Drug: Single Ascending Dose of SAB-1763 mL (~225 mg) SAB-176 dose |
| Placebo 3mL | Placebo comparator | Drug: Single Ascending Dose of PlaceboNormal Saline |
| SAB-176 5mL | Experimental | Drug: Single Ascending Dose of SAB-1765 mL (~375 mg) SAB-176 dose |
| Placebo 5mL | Placebo comparator | Drug: Single Ascending Dose of PlaceboNormal Saline |
| SAB-176 20mL | Experimental | Drug: Single Ascending Dose of SAB-17620 mL (~1500 mg) SAB-176 dose |
| Placebo 20mL | Placebo comparator | Drug: Single Ascending Dose of PlaceboNormal Saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Healthy adult, male or female, aged 18 to 60 years (inclusive) at the time of enrollment.
- 2. Completion and review of assessment of understanding test (achieved > 70% accuracy).
- 3. Signed informed consent document. 4. Available for the required follow-up period and scheduled clinic visits. 5. Women of childbearing potential: Negative urine pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within two (2) months following investigational product administration.
- 6. Willing to use an acceptable method of contraception during the study and for 2 months following investigational product administration. If a barrier method is the contraceptive of choice, concurrent use of a spermicide will be recommended.
- 7. Body mass index (BMI) between 19 and 35 kg/m2. 8. Agree to refrain from blood donation during the study and for at least 12 months (1 year) following injection with the study drug.
Key exclusion criteria (16 listed)
- 1. Health problems (for example, intercurrent febrile illness, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension, or any other condition that might place the subject at increased risk of adverse events); study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion.
- 2. Clinically significant abnormalities on physical examination that, in the PI's opinion, would place the subject at undue risk and/or preclude full evaluation of potential adverse events.
- 3. Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or inherited or acquired immunodeficiency (including IgA deficiency; defined by serum IgA <7 mg/dL).
- 4. Women who are pregnant or planning to become pregnant during the study period plus 2 months beyond the last received dose, and currently nursing women.
- 5. History of buttock enhancement (e.g., silicone enhancement or implants) that may interfere with intramuscular injections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single Ascending Dose of SAB-176Also: SAB-176Single ascending dose | Drug | SAB-176 1 mL, SAB-176 20mL, SAB-176 3mL, SAB-176 5mL |
| Single Ascending Dose of PlaceboAlso: PlaceboSingle ascending dose | Drug | Placebo 1mL, Placebo 20mL, Placebo 3mL, Placebo 5mL |
Primary outcome
Occurrence of solicited local and systemic adverse events (AEs) through Day 29.
Time frame: Dosing through Day 29
Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
Occurrence of IP-related unsolicited AEs through Day 61.
Time frame: Dosing through Day 61
Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
Occurrence of serious adverse events (SAEs) through Day 61.
Time frame: Dosing through Day 61
Solicited AEs will be collected after administration of the investigational product up to 28 days post-injection. Unsolicited AEs will be collected until the last study visit (up to Day 61). AEs will be summarized for the number of subjects who experience an AE or the number of AE events by analysis group, MedDRA category, severity grading scale, and post-baseline timepoint.
9 secondary outcomes
Hemagglutination Inhibition (HAI) against influenza A strains (H1N1, H3N2)
Time frame: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Microneutralization (MN) titers against influenza A strains (H1N1, H3N2)
Time frame: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Hemagglutination Inhibition (HAI) against influenza B strains (B-Victoria lineage, B/Yamagata lineage)
Time frame: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Microneutralization (MN) titers against influenza B strains (B-Victoria lineage, B/Yamagata lineage)
Time frame: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Maximum titer value (Cmax)
Time frame: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Time of maximum titer value (Tmax)
Time frame: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Terminal phase elimination rate constant (λZ)
Time frame: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Terminal elimination half-life (t½)
Time frame: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Area under the curve (AUC)
Time frame: 1 hour post dose, Day 1, Day 8, Day 14, Day 28, Day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nehkonti Adams, MD principal investigator
Naval Medical Research Command (NMRC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single Ascending Dose of SAB-176 in people with PHA1A, run by SAb Biotherapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of solicited local and systemic adverse events (AEs) through Day 29. (time frame: Dosing through Day 29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.