Influenza A H1N1Phase 2NCT04850898
Study of SAB-176 in Healthy Adult Participants
A Phase 2 study testing SAB-176 in people with Influenza A H1N1, run by SAb Biotherapeutics, Inc. at 1 site in United Kingdom.
Trial summary
Healthy adult participants will be challenged with the H1N1 Influenza virus and then treated with either SAB-176 or placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza A H1N1
- What is being tested?
- SAB-176
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jun 2021to 8 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- An informed consent document signed and dated by the participant and the investigator
- Aged between 18 and 45 years on the day of signing the study specific ICF.
- In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the investigator.
- A documented medical history prior to enrollment.
- The following criteria are applicable to female participants:
- Females of childbearing potential must have a negative pregnancy test prior to enrollment.
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- Females of non-childbearing potential:
- A.) Post-menopausal females: defined as having a history of amenorrhea for >12 months with no alternative medical cause, and/or by follicle stimulating hormone (FSH) level >40mIU/mL, confirmed by laboratory.
- b.) Documented status as being surgically sterile (e.g. tubal ligation, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).
- The following criteria apply to female and male participants:
- a.) Female participants of childbearing potential must use one form of highly effective contraception. Hormonal methods must be in place from at least 2 weeks prior to the first study visit. The contraception used must continue until 28 days after the date of dosing with Investigational Medicinal Product (IMP)> Highly effective contraception is as described below:
- -Established use of hormonal methods of contraception described below (for a minimum of 2 weeks prior to the first study visit). When hormonal methods of contraception are used, male partners are required to use a condom with a spermicide: i.) Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: Oral, Intravaginal, or Transdermal ii.) progestogen-only hormonal contraception associated with inhibition of ovulation: Oral, Injectable, or Implantable
- b.) Intrauterine device c.) Intrauterine hormone-releasing system d.) bilateral tubal ligation e.) Male sterilization (with the appropriate post vasectomy documentation of the absence of sperm in the ejaculate) where the vasectomised male is the sole partner for that woman.
- f.) True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
- B.) Male participants must agree to the contraceptive requirements below at entry to quarantine and continuing until 28 days after the date of dosing with IMP:
- Use a condom with a spermicide to prevent pregnancy in a female partner or to prevent exposure of any partner (male and female) to the IMP.
- Male sterilization with the appropriate post vasectomy documentation of the absence of sperm in in the ejaculate (please note that the use of condom with spermicide will still be required to prevent partner exposure).
- In addition, for female partners of childbearing potential, that partner must use another form of contraception such as one of the highly effective methods mentioned above for female participants.
- True abstinence - sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.
- C.) In addition to the contraceptive requirements above, male participants must agree not to donate sperm following discharge from quarantine until 28 days after the date of dosing with IMP.
- Serosuitable to the Challenge virus, as defined in the study Analytical Plan (AP).
Who cannot join
- (Participants are excluded from the study if any of the following criteria apply)
- 1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit.
- 2.
- Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety).
- And/or other major disease that, in the opinion of the investigator, may put the participant at undue risk, or interfere with a participant completing the stud and necessary investigations.
- The following conditions apply:
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- Participants with clinically mild atopic eczema/atopic dermatitis and clinically mild psoriasis may be included at the Investigator's discretion (e.g., if small amounts of regular topical steroids are used, no eczema in cubital fossa; moderate to large amounts of daily dermal corticosteroids is an exclusion).
- Rhinitis (including hay fever) which is clinically active or history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine will be excluded. Participants with a history of currently inactive rhinitis (within the last 30 days) or mild rhinitis may be included at the PI's discretion.
- Participants with a physician diagnosed underactive thyroid who have been controlled on treatment for at least 6 months with evidence of a normal thyroid function test can be included at the discretion of the PI.
- Any concurrent serious illness including history of malignancy that may interfere with the aims of the study or a participant completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion.
- Participants with a history of psychiatric illness including depression and/or anxiety of any severity within the last 2 years can be included if the Patient Health Questionnaire (PHQ-9) and / or the Generalised Anxiety Disorder Questionnaire (GAD-7) is less than or equal to 4. Participants with a PHQ-9 or GAD-7 score of between 5 and 9 may be included following consultation with a Senior Physician (Clinical Lead for Screening) who may advise further consultation with the PI.
- Participants reporting physician diagnosed migraine can be included provided there are no associated neurological symptoms such as hemiplegia or visual loss. Cluster headache/migraine or prophylactic treatment for migraine is an exclusion.
- Participants with physician diagnosed mild irritable bowel syndrome not requiring regular treatment can be included at the discretion of the PI.
- 3. Participants who have smoked ≥10 pack years at any time (10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years).
- 4. A total body weight ≤50 kg or body mass index (BMI) ≤18 kg/m2 or ≥35 kg/m2.
- 5. Females who: a) Are breastfeeding, or b) Have been pregnant within 6 months prior to the study.
- 6. History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.
- 7. Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
- Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge, (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded).
- Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalised due to epistaxis on any previous occasion.
- Any nasal or sinus surgery within 3 months of the first study visit.
- PRIOR or CONCOMITANT MEDICATIONS AND ASSESSMENTS
- 9.
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- Evidence of vaccinations within the 4 weeks prior to the planned date of viral challenge, unless medically necessary (e.g., during an outbreak or pandemic situation) and at the PI's discretion.
- Intention to receive any vaccination(s) before the day of Follow-up visit. (NB. No travel restrictions will apply after the Day 28 Follow-up visit).
- Receipt of influenza vaccine in the last 6 months prior to the planned date of viral challenge.
- 10. Receipt of blood or blood products, or loss (including blood donations) of 470 mL or more of blood during the 3 months prior to the planned date of viral challenge or planned during the 3 months after the final visit.
- 11.
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- Receipt of any investigational drug within 3 months prior to the planned date of viral challenge.
- Receipt of three or more investigational drugs within the previous 12 months prior to the planned date of viral challenge.
- Prior inoculation with a virus from the same virus-family as the Challenge virus.
- Prior participation in another Human Viral Challenge (HVC) study with a respiratory virus in the preceding 3 months, taken from the date of viral challenge in the previous study to the date of expected viral challenge in this study.
- Receipt of Polyclonal Antibodies (pAbs) or biologic within the previous 12 months prior to the planned date of viral challenge.
- 12.
- Confirmed positive test for drugs of abuse and cotinine on first study visit. One repeat test allowed at PI discretion.
- History or presence of alcohol addiction, or excessive use of alcohol (weekly intake in excess of 28 units alcohol; 1 unit being a half glass of beer, a small glass of wine or a measure of spirits), or excessive consumption of xanthine containing substances (e.g., daily intake in excess of 5 cups of caffeinated drinks e.g., coffee, tea, cola).
- 13. A forced expiratory volume in 1 second (FEV1) <80%.
- 14. Positive HIV, active hepatitis A, B, or C test.
- 15. Those employed or immediate relatives of those employed at hVIVO or the Sponsor.
- 16. Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Mary BioEnterprises Innovation Centre
London, E1 2AX
About this study
Official title: A Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Treatment Efficacy of SAB-176 (a Quadrivalent Anti-seasonal Influenza Immunoglobulin Product) in an H1N1 Challenge Model in Healthy Adult Participants
Healthy adult participants will be challenged with the H1N1 Influenza virus and then treated with either SAB-176 or placebo.
Read the detailed description
Up to 60 eligible participants will be randomized in a 1:1 ratio to receive either SAB-176 (up to 25 mg/kg dose) or placebo. Healthy adult participants will be pre-screened for serosuitability for Influenza A/California/2009 H1N1 challenge virus. Serosuitable participants who sign the study specific informed consent form (ICF) will be challenged with an intranasal administration of Influenza A/California/2009 H1N1 virus on Day 0. Participants will be given intravenous (IV) infusion of SAB-176 or placebo on Day 1. Participants will be held in quarantine until Day 8.
- Conditions
- Influenza A H1N1
- Being tested
- SAB-176, Placebo
- Medical subject headings
- Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAB-176Biological
Treatment of influenza
PlaceboOther
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline Placebo Control | Placebo comparator | Placebo control dosed 1 time via intravenous infusion Receives: Other: Placebo |
| SAB-176 - 25mg/kg | Experimental | Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion Receives: Biological: SAB-176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate Viral Load by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) of SAB-176 When Compared to Placebo
Area under the viral load-time curve (VL-AUC) of Influenza A/California/2009 H1N1 virus, as determined by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) on nasal samples.
Measured: 28 Days
Secondary outcomes (13)
Evaluate Peak Viral Load Quantified by qRT-PCR.
Peak viral load as defined by the maximum viral load determined by quantifiable qRT-PCR measurements to evaluate the effect of SAB-176 in reducing viral loads in qRT-PCR due to Influenza A/California/2009 H1N1 virus compared to placebo.
Measured: 28 Days
Evaluate Duration of Influenza Quantified by qRT-PCR.
Duration in hours of Influenza quantifiable qRT-PCR measurements to evaluate the effect of SAB-176 in reducing the duration of Influenza in qRT-PCR due to Influenza A/California/2009 H1N1 virus compared to placebo.
Measured: 28 Days
Evaluate Peak Viral Load Determined by Cell Culture.
Peak viral load as defined by the maximum viral load determined by quantifiable cell culture to evaluate the effect of SAB-176 in reducing viral loads in cell culture due to Influenza A/California/2009 H1N1 virus, compared to placebo.
Measured: 28 Days
Evaluate Peak Viral Load Area Under the Curve Determined by Cell Culture.
VL-AUC of Influenza A/California/2009 H1N1 virus as determined by cell culture to evaluate the effect of SB-176 in reducing viral loads in cell culture due to Influenza A/California/2009 H1N1 virus, compared to placebo.
Measured: 28 Days
Duration of Influenza Using Peak Viral Load Determined by Cell Culture.
Duration measured in hours of influenza quantifiable by cell culture measurement to evaluate the effect of SB-176 in reducing viral loads in cell culture due to Influenza A/California/2009 H1N1 virus, compared to placebo.
Measured: 28 Days
TSS-AUC (Area Under the Curve Over Time of Total Clinical Symptoms Score) Measured by Graded Symptom Scoring System to Evaluate the Effect of SAB-176 in Reducing Symptoms Due to Influenza A/California/2009 H1N1 Virus Compared to Placebo.
Using the hVIVO Symptom Diary Card, participants grade 11 distinct cold symptoms on a scale of 0-3 (Grade 0: No symptoms; Grade 1: just noticeable; Grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; Grade 3: Quite bothersome most or all the time, and it stops me participating in activities) and Shortness of Breath and Wheeze have a scale of 0-4 with 0-3 being the same and grade 4 being symptoms at rest. Additional to symptom card, a Visual Analogue Scale dairy card using a 0mm to 100mm scale, with the same 13 symptoms with 0mm being no symptoms. Total summed grading scale is 0 to 1341. Lower scores represent a better outcome.
Measured: 28 Days
Peak Symptom Diary Card Score
Peak symptom diary card score: peak total clinical symptoms (TSS) as measured by graded symptom scoring system to evaluate the effect of SAB-176 in reducing symptoms due to Influenza A/California/2009 H1N1 virus compared to placebo.
Using the hVIVO Symptom Diary Card, participants grade 11 distinct cold symptoms on a scale of 0-3 (Grade 0: No symptoms; Grade 1: just noticeable; Grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; Grade 3: Quite bothersome most or all the time, and it stops me participating in activities) and Shortness of Breath and Wheeze have a scale of 0-4 with 0-3 being the same and grade 4 being symptoms at rest. Additional to symptom card, a Visual Analogue Scale dairy card using a 0mm to 100mm scale, with the same 13 symptoms with 0mm being no symptoms. Total summed grading scale is 0 to 1341. Lower scores represent a better outcome.
Measured: 28 Days
Peak Daily Symptom Score
Peak symptom diary card score: The individual maximum daily sum of symptom score; peak TSS as measured by graded symptom scoring system to evaluate the effect of SAB-176 in reducing symptoms due to Influenza A/California/2009 H1N1 virus compared to placebo.
Using the hVIVO Symptom Diary Card, participants grade 11 distinct cold symptoms on a scale of 0-3 (Grade 0: No symptoms; Grade 1: just noticeable; Grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; Grade 3: Quite bothersome most or all the time, and it stops me participating in activities) and Shortness of Breath and Wheeze have a scale of 0-4 with 0-3 being the same and grade 4 being symptoms at rest. Additional to symptom card, a Visual Analogue Scale dairy card using a 0mm to 100mm scale, with the same 13 symptoms with 0mm being no symptoms. Total summed grading scale is 0 to 1341. Lower scores represent a better outcome.
Measured: 28 Days
Percent of Participants With Grade 2 or Higher Symptoms.
Number (percent) of participants with Grade 2 or higher symptoms to evaluate the effect of SAB-176 in reducing symptoms due to Influenza A/California/2009 H1N1 virus compared to placebo.
Measured: 28 Days
RT-PCR Confirmed Symptomatic Influenza Infection.
RT-PCR-confirmed influenza infection (any 2 quantifiable [≥ lower limit of quantification {LLOQ}] qRT-PCR measurements reported) over 4 consecutive scheduled timepoints, from morning of Day 2 up to Day 8 (discharge from quarantine) AND clinical symptoms (grade 2 or more symptoms) between Day 2 and quarantine discharge.
Measured: 28 Days
Culture Lab-confirmed Reduction of Symptomatic Influenza Infection.
Culture lab-confirmed reduction of symptomatic influenza infection defined as: lab-confirmed culturable influenza infection and clinical symptoms to evaluate the effect of SAB-176 in reducing the incidence of symptomatic infection due to Influenza A/California/2009 H1N1 virus compared to placebo.
Measured: 28 Days
Total Number of Participants That Any Adverse Event (AE) Was Reported for Which Occurred Across All Participants From IV Infusion up to Day 28 Follow-up.
Total number of participants that any adverse events (AEs) that occurred across all participants was reported; Captured from IV infusion up to Day 28 follow-up to evaluate the safety of SAB-176 when compared to placebo.
Measured: 28 Days
Occurrence of Serious Adverse Events (SAEs) From IV Infusion up to Day 28 Follow up.
Total number, by occurrence, of serious adverse events (SAEs) from IV infusion up to Day 28 follow up to evaluate the safety of SAB-176 when compared to placebo.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start23 Jun 2021
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza A H1N1Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory randomised, Phase 2a, double blind, placebo-controlled study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- SAb Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hvivo
- Responsible party
- Sponsor
- Investigators
- Victoria Parker, Principal investigator, hVIVO Services Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850898
- Sponsor's protocol ID
- SAB-176-201
- Status last verified
- Dec 2024
- First submitted
- 6 Apr 2021
- Last updated
- 22 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Treatment Efficacy of SAB-176 (a Quadrivalent Anti-seasonal Influenza Immunoglobulin Product) in an H1N1 Challenge Model in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT04850898
- Acronym / sponsor ID
- SAB-176-201
- Conditions
- Influenza A H1N1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- SAb Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hvivo
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy adult participants will be challenged with the H1N1 Influenza virus and then treated with either SAB-176 or placebo.
Detailed description
Up to 60 eligible participants will be randomized in a 1:1 ratio to receive either SAB-176 (up to 25 mg/kg dose) or placebo. Healthy adult participants will be pre-screened for serosuitability for Influenza A/California/2009 H1N1 challenge virus. Serosuitable participants who sign the study specific informed consent form (ICF) will be challenged with an intranasal administration of Influenza A/California/2009 H1N1 virus on Day 0. Participants will be given intravenous (IV) infusion of SAB-176 or placebo on Day 1. Participants will be held in quarantine until Day 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Exploratory randomised, Phase 2a, double blind, placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| Normal Saline Placebo Control | Placebo comparator | Other: PlaceboPlacebo control dosed 1 time via intravenous infusion |
| SAB-176 - 25mg/kg | Experimental | Biological: SAB-176Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- An informed consent document signed and dated by the participant and the investigator
- Aged between 18 and 45 years on the day of signing the study specific ICF.
- In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the investigator.
- A documented medical history prior to enrollment.
- The following criteria are applicable to female participants:
Key exclusion criteria (42 listed)
- (Participants are excluded from the study if any of the following criteria apply)
- 1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit.
- 2.
- Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety).
- And/or other major disease that, in the opinion of the investigator, may put the participant at undue risk, or interfere with a participant completing the stud and necessary investigations.
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-176Treatment of influenza | Biological | SAB-176 - 25mg/kg |
| PlaceboPlacebo Control | Other | Normal Saline Placebo Control |
Primary outcome
To Evaluate Viral Load by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) of SAB-176 When Compared to Placebo
Time frame: 28 Days
Area under the viral load-time curve (VL-AUC) of Influenza A/California/2009 H1N1 virus, as determined by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) on nasal samples.
13 secondary outcomes
Evaluate Peak Viral Load Quantified by qRT-PCR.
Time frame: 28 Days
Evaluate Duration of Influenza Quantified by qRT-PCR.
Time frame: 28 Days
Evaluate Peak Viral Load Determined by Cell Culture.
Time frame: 28 Days
Evaluate Peak Viral Load Area Under the Curve Determined by Cell Culture.
Time frame: 28 Days
Duration of Influenza Using Peak Viral Load Determined by Cell Culture.
Time frame: 28 Days
TSS-AUC (Area Under the Curve Over Time of Total Clinical Symptoms Score) Measured by Graded Symptom Scoring System to Evaluate the Effect of SAB-176 in Reducing Symptoms Due to Influenza A/California/2009 H1N1 Virus Compared to Placebo.
Time frame: 28 Days
Peak Symptom Diary Card Score
Time frame: 28 Days
Peak Daily Symptom Score
Time frame: 28 Days
Percent of Participants With Grade 2 or Higher Symptoms.
Time frame: 28 Days
RT-PCR Confirmed Symptomatic Influenza Infection.
Time frame: 28 Days
Culture Lab-confirmed Reduction of Symptomatic Influenza Infection.
Time frame: 28 Days
Total Number of Participants That Any Adverse Event (AE) Was Reported for Which Occurred Across All Participants From IV Infusion up to Day 28 Follow-up.
Time frame: 28 Days
Occurrence of Serious Adverse Events (SAEs) From IV Infusion up to Day 28 Follow up.
Time frame: 28 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Victoria Parker principal investigator
hVIVO Services Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAB-176 in people with Influenza A H1N1, run by SAb Biotherapeutics, Inc. at 1 site in United Kingdom.
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 21 inclusion and 42 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 22 Jan 2025. 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 Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Evaluate Viral Load by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) of SAB-176 When Compared to Placebo (time frame: 28 Days). 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 22 Jan 2025.