COVID-19Phase 1NCT04468958
Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants
A Phase 1 study testing SAB-185 and Normal saline in people with COVID-19 and SARS-CoV2, run by SAb Biotherapeutics, Inc. at 3 sites in United States.
Trial summary
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- SAB-185 and Normal saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2020to 23 Dec 2020
- 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
- Subjects must meet all of the following criteria for inclusion:
- 18-60 years of age
- Able to understand the study and comply with all study procedures
- Agrees not to participate in any other trial of an investigational product during the study period
- Willing and able to provide written informed consent prior to the start of any study related activities
- In good health in the opinion of the site principal investigator as determined by vital signs, medical history, physical examination and clinical laboratory tests
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- If female, meets at least one of the following reproductive risk criteria
- Post-menopausal for at least 12 months
- Use of one or more of the following highly effective contraceptive methods for at least 90 days following the last dose of study product: combined estrogen and progestogen containing or progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system, surgical bilateral tubal occlusion
- Vasectomized sole sexual partner who has received medical assessment of the surgical success
- Subjects agree to sexual abstinence (refraining from heterosexual intercourse for at least 90 days following the last dose of study product) if not using birth control or condoms for males.
Who cannot join
- Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- Treatment or participation in another clinical trial of any other investigational agent within 30 days prior to enrollment.
- Use of other drugs that, in the opinion of the investigator, could complicate analysis of SAB-185.
- Subjects with the following risk factors:
- Compromised immune system including confirmed diagnosis of current cancer under treatment, inherited deficiencies of the immune system, immune suppressing medication, or other conditions causing leukopenia or neutropenia
- Known autoimmune condition requiring therapy more intensive than intermittent non-steroidal anti-inflammatories in the prior 6 months (for example: rheumatoid arthritis, lupus, inflammatory bowel disease)
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- Chronic respiratory disease including COPD, emphysema, cystic fibrosis, pulmonary hypertension, or other chronic condition that requires the routine use of supplemental oxygen
- Chronic asthma requiring the use of oral steroids or hospitalization in the last six months
- Renal failure or renal insufficiency requiring dialysis
- Congestive heart failure or significant atherosclerotic disease (coronary artery disease or peripheral vascular disease)
- Hypertension, diabetes, those currently vaping or smoking or with a history of chronic smoking, and those with BMI > 35 kg/m2
- Receipt of pooled immunoglobulin or plasma in past 30 days
- Any other underlying medical (cardiac, liver, renal, neurological, respiratory) or psychiatric condition that in the view of the investigator would preclude use of SAB-185
- Known IgA deficiency or previous allergic reaction to intravenous immunoglobin (IVIG)/subcutaneous immunoglobin (SCIG)
- Positive screening test for hepatitis B virus surface antigen, hepatitis C virus antibody, or HIV antibody
- Positive screening test for rheumatoid factor
- History of COVID-19
- Positive FDA-authorized screening test for serum SARS-CoV-2 antibody or presence of SARS-CoV-2 on nasopharyngeal or oropharyngeal swab by FDA-authorized RT-PCR
- History of allergy, anaphylaxis, or severe reaction to beef products (including milk and gelatin).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
ICON Early Phase Services
San Antonio, Texas, 78209
SUNY Upstate Medical University
Syracuse, New York, 13210
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67205
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185 in Healthy Subjects
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in healthy participants.
Read the detailed description
There were 4 treatment groups and 1 control group. Cohort 1 received 1 dose of SAB-185 at 10 mg/kg per dose. Cohort 2 received 1 dose of SAB-185 at 25 mg/kg, Cohort 3 received 2 doses of SAB-185 at 25 mg/kg each 7 days apart, and Cohort 4 received 1 dose of SAB-185 at 50 mg/kg per dose. All the doses were prepared at the site by the pharmacy staff or designee for delivery to the clinical staff for administration, per the site's SOPs.
- Being tested
- SAB-185, Normal saline
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAB-185Biological
Also called Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)
SAB-185 is a purified human immunoglobulin G (hIgG) designed to specifically bind to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viruses. SAB-185 is purified from the plasma of immunized Tc bovines that were immunized initially (vaccinations 1 and 2) with a plasmid DNA (pDNA) vaccine that expresses wild-type SARS-CoV-2 spike protein, followed by additional immunizations (vaccinations 3 and beyond) with a recombinant spike protein from SARS-CoV-2 produced in insect cells. The purified hIgG is a sterile liquid formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5. The drug product will be administered intravenously and will be diluted in saline per the clinical protocol.
Normal salineOther
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
| Study group | Role | What they receive |
|---|---|---|
| 10mg/kg SAB-185 | Experimental | 10mg/kg SAB-185 in normal (0.9%) saline; concentration 4mg/mL (0.4%) Receives: Biological: SAB-185 |
| 25mg/kg SAB-185 | Experimental | 25mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%) Receives: Biological: SAB-185 |
| 25mg/kg SAB-185 x 2 doses | Experimental | 25mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%). Cohort 3 will receive a second 25mg/kg dose of SAB-185 7 days (+/-2) after the first treatment. Receives: Biological: SAB-185 |
| 50mg/kg SAB-185 | Experimental | 50mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%) Receives: Biological: SAB-185 |
| Placebo | Placebo comparator | Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Having Adverse Events
Incidence and severity of other adverse events and severe adverse events (SAE)
Measured: 29 Days
Number of Participants Having Transfusion-Related Adverse Events
transfusion-related adverse events
Measured: 29 Days
Secondary outcomes (2)
Number of Participants Having Adverse Events
Incidence and severity of adverse events and SAEs from Screening through Study Day 90
Measured: 90 Days
Pharmacokinetics from screening to day 90
SARS-CoV-2 binding (ELISA) and neutralizing (PRNT80) antibody titers from Screening through Study Day 90
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start1 Jul 2020
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- SAb Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services, Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
- Responsible party
- Sponsor
- Investigators
- David Hoover, MD, Principal investigator, ICON GPHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468958
- Sponsor's protocol ID
- SAB-185-101
- Status last verified
- Jun 2022
- First submitted
- 8 Jul 2020
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article, after deidentification (test, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04468958
- Acronym / sponsor ID
- SAB-185-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SAb Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services, Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 13 Jul 2020 (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.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). SAB Biotherapeutics has developed SAB-185, an Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (transchromosomic [Tc] bovine-derived), as a potential therapeutic to treat COVID-19. This study will evaluate the safety, immunogenicity, and pharmacokinetics of SAB-185 in healthy participants.
Detailed description
There were 4 treatment groups and 1 control group. Cohort 1 received 1 dose of SAB-185 at 10 mg/kg per dose. Cohort 2 received 1 dose of SAB-185 at 25 mg/kg, Cohort 3 received 2 doses of SAB-185 at 25 mg/kg each 7 days apart, and Cohort 4 received 1 dose of SAB-185 at 50 mg/kg per dose. All the doses were prepared at the site by the pharmacy staff or designee for delivery to the clinical staff for administration, per the site's SOPs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 10mg/kg SAB-185 | Experimental | Biological: SAB-18510mg/kg SAB-185 in normal (0.9%) saline; concentration 4mg/mL (0.4%) |
| 25mg/kg SAB-185 | Experimental | Biological: SAB-18525mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%) |
| 25mg/kg SAB-185 x 2 doses | Experimental | Biological: SAB-18525mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%). Cohort 3 will receive a second 25mg/kg dose of SAB-185 7 days (+/-2) after the first treatment. |
| 50mg/kg SAB-185 | Experimental | Biological: SAB-18550mg/kg SAB-185 in normal (0.9%) saline; concentration 20mg/mL (2%) |
| Placebo | Placebo comparator | Other: Normal salineNormal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18-60 years of age
- Able to understand the study and comply with all study procedures
- Agrees not to participate in any other trial of an investigational product during the study period
- Willing and able to provide written informed consent prior to the start of any study related activities
- In good health in the opinion of the site principal investigator as determined by vital signs, medical history, physical examination and clinical laboratory tests
Key exclusion criteria (19 listed)
- Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- Treatment or participation in another clinical trial of any other investigational agent within 30 days prior to enrollment.
- Use of other drugs that, in the opinion of the investigator, could complicate analysis of SAB-185.
- Subjects with the following risk factors:
- Receipt of pooled immunoglobulin or plasma in past 30 days
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 |
|---|---|---|
| SAB-185Also: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)SAB-185 is a purified human immunoglobulin G (hIgG) designed to specifically bind to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viruses. SAB-185 is purified from the plasma of immunized Tc bovines that were immunized initially (vaccinations 1 and 2) with a plasmid DNA (pDNA) vaccine that expresses wild-type SARS-CoV-2 spike protein, followed by additional immunizations (vaccinations 3 and beyond) with a recombinant spike protein from SARS-CoV-2 produced in insect cells. The purified hIgG is a sterile liquid formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5. The drug product will be administered intravenously and will be diluted in saline per the clinical protocol. | Biological | 10mg/kg SAB-185, 25mg/kg SAB-185, 25mg/kg SAB-185 x 2 doses, 50mg/kg SAB-185 |
| Normal salineNormal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm. | Other | Placebo |
Primary outcome
Number of Participants Having Adverse Events
Time frame: 29 Days
Incidence and severity of other adverse events and severe adverse events (SAE)
Number of Participants Having Transfusion-Related Adverse Events
Time frame: 29 Days
transfusion-related adverse events
2 secondary outcomes
Number of Participants Having Adverse Events
Time frame: 90 Days
Pharmacokinetics from screening to day 90
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article, after deidentification (test, tables, figures, and appendices)
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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.
David Hoover, MD principal investigator
ICON GPHS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAB-185 and Normal saline in people with COVID-19 and SARS-CoV2, run by SAb Biotherapeutics, Inc. at 3 sites 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 11 inclusion and 19 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: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants Having Adverse Events (time frame: 29 Days). The study lists 2 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 1 Jul 2022.