CompletedPhase 2

Study of SAB-176 in Healthy Adult Participants

United Kingdom62 participantsStarted 2021-06-23

Plain-language summary

Healthy adult participants will be challenged with the H1N1 Influenza virus and then treated with either SAB-176 or placebo.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. The following criteria apply to female and male participants:
✓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
✓. 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.

Exclusion criteria

✕. 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.
✕. 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.
✕. 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.

What they're measuring

To Evaluate Viral Load by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) of SAB-176 When Compared to Placebo

Timeframe: 28 Days

Trial details

NCT IDNCT04850898

SponsorSAb Biotherapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-08

Results submitted2023-02-10

View on ClinicalTrials.gov More Influenza A H1N1 trials