Study of SAB-176 in Healthy Adult Participants
Influenza A H1N1
Bottom Line
View on ClinicalTrials.gov: NCT04850898 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SAB-176 (Biological); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- SAb Biotherapeutics, Inc.
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Evaluate Viral Load by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) of SAB-176 When Compared to Placebo |
273.05; 91.98 | — |
| SECONDARY Evaluate Peak Viral Load Quantified by qRT-PCR. |
3.8196; 2.5440 | — |
| SECONDARY Evaluate Duration of Influenza Quantified by qRT-PCR. |
1.3097; 0.5503 | — |
| SECONDARY Evaluate Peak Viral Load Determined by Cell Culture. |
1.3097; 0.5503 | — |
| SECONDARY Evaluate Peak Viral Load Area Under the Curve Determined by Cell Culture. |
67.97; 7.99 | — |
| SECONDARY Duration of Influenza Using Peak Viral Load Determined by Cell Culture. |
1.3097; 0.5503 | — |
| SECONDARY 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. |
166.52; 51.06 | — |
| SECONDARY Peak Symptom Diary Card Score |
3.7; 1.8 | — |
| SECONDARY Peak Daily Symptom Score |
8.3; 3.6 | — |
| SECONDARY Percent of Participants With Grade 2 or Higher Symptoms. |
30; 20.7 | — |
| SECONDARY RT-PCR Confirmed Symptomatic Influenza Infection. |
15; 9 | — |
| SECONDARY Culture Lab-confirmed Reduction of Symptomatic Influenza Infection. |
6; 2 | — |
| SECONDARY 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. |
16; 18 | — |
| SECONDARY Occurrence of Serious Adverse Events (SAEs) From IV Infusion up to Day 28 Follow up. |
0; 0 | — |
Summary
Eligibility Criteria
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:
- 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:
- 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
Data sourced from ClinicalTrials.gov (NCT04850898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.