Study of SAB-176 in Healthy Adult Participants

NCT04850898 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: SAB-176-201
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza A H1N1

Outcome Measures

Primary Outcomes (1)

• 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.

  28 Days

Secondary Outcomes (13)

• Evaluate Peak Viral Load Quantified by qRT-PCR.

  28 Days

• Evaluate Duration of Influenza Quantified by qRT-PCR.

  28 Days

• Evaluate Peak Viral Load Determined by Cell Culture.

  28 Days

• Evaluate Peak Viral Load Area Under the Curve Determined by Cell Culture.

  28 Days

• Duration of Influenza Using Peak Viral Load Determined by Cell Culture.

  28 Days

Other Outcomes (5)

• Number of Participants With Upper Respiratory Tract Illness.

  28 Days

• Number of Participants With Lower Respiratory Tract Illness.

  28 Days

• Number of Participants With Systemic Illness.

  28 Days

Study Arms (2)

Normal Saline Placebo Control

PLACEBO COMPARATOR

Placebo control dosed 1 time via intravenous infusion

Other: Placebo

SAB-176 - 25mg/kg

EXPERIMENTAL

Investigational Medicinal Product dosed 1 time at 25 mg/kg on day 1 via intravenous infusion

Biological: SAB-176

Interventions

SAB-176 BIOLOGICAL

Treatment of influenza

SAB-176 - 25mg/kg

Placebo OTHER

Placebo Control

Normal Saline Placebo Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• (Participants are excluded from the study if any of the following criteria apply)
• \. 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.
• 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:
• 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.
• 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 with physician diagnosed mild irritable bowel syndrome not requiring regular treatment can be included at the discretion of the PI.
• \. 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).
• \. A total body weight ≤50 kg or body mass index (BMI) ≤18 kg/m2 or ≥35 kg/m2.
• \. Females who: a) Are breastfeeding, or b) Have been pregnant within 6 months prior to the study.
• \. History of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the PI.
• \. 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.

Sponsors & Collaborators

• SAb Biotherapeutics, Inc.: lead
• Hvivo: collaborator

Study Sites (1)

Queen Mary BioEnterprises Innovation Centre

London, E1 2AX, United Kingdom

Location

MeSH Terms

Conditions

Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Senior Director Clinical Operations
• Organization: SAB Biotherapeutics

ssinclair@sabbio.com

8326221699

Study Officials

• Victoria Parker

  hVIVO Services Limited

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Exploratory randomised, Phase 2a, double blind, placebo-controlled study.

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 20, 2021
• Study Start: June 23, 2021
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)