Phase
Condition
Influenza
Treatment
Placebo for VNT-101
VNT-101
Clinical Study ID
Ages 18-59 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provides written informed consent prior to the initiation of any trial procedures.
Able to understand and agrees to comply with all planned trial procedures and beavailable for all study visits.
Healthy, adult, male or female (of non-childbearing potential only*), 18-59 years ofage, inclusive, at the screening visit.
- Female participants of non-childbearing potential must be either surgicallysterile (i.e., hysterectomy, bilateral tubal ligation, bilateral tubal occlusion [hysteroscopic sterilization], salpingectomy, and/or bilateral oophorectomy at least 26 weeks before Screening) or post-menopausal, defined as spontaneous amenorrhea forat least a year, with follicle-stimulating hormone (FSH) in the post-menopausalrange at Screening, based on the central laboratory ranges.
- Continuous non-smoker who has not used nicotine-, tobacco-, cannabis-, orcannabidiol-containing products** prior to the first dosing based on participantself-reporting.
**The period before first dose is at least 3 months for tobacco and associatedproducts and at least 60 days for cannabis and associated products.
Body mass index (BMI)>/=18.0 and </= 30.0 kg/m^2 at the screening visit.
Medically healthy*** with no clinically significant medical history, physicalexamination, laboratory profiles, vital signs, and ECGs, as deemed by the PrincipalInvestigator (PI) or designee,
***Including the following:
Supine diastolic blood pressure is >/= 40 mmHg and </= 90 mmHg at the screeningvisit.
Supine systolic blood pressure is >/= 90 mmHg and </= 140 mmHg at the screeningvisit.
Supine heart rate is >/= 60 bpm and</= 100 bpm at the screening visit.
QTcF interval is </= 460 msec (males) and </=470 msec (females) and has ECGfindings considered normal or not clinically significant by the PI or designeeat the screening visit.
Estimated creatinine clearance >/= 80 mL/min based on the Cockroft-Gaultequation and creatinine <1.50 mg/dL at the screening visit.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is notgreater than 1.1 times the upper limit of normal (ULN), as specified by thetesting laboratory.
Other clinical laboratory values within normal range as specified by thetesting laboratory, unless deemed not clinically significant by the PI ordesignee.
Must agree to refrain from using tanning salons, saunas, sunbathing, or prolongedsun exposure during participation in the study through the follow-up visit.
Male participants must agree not to donate sperm during the study and for 90 daysfollowing the last administration of Study Product.
Male participants must agree to use a medically accepted contraceptive regimen****during participation and for 30 days after last administration of the study productor be vasectomized.
- Acceptable methods of contraception include abstinence from intercourse with afemale of childbearing potential or use of male condoms with spermicide orsurgical sterilization (vasectomy) of participant at least 26 weeks before theScreening.
Exclusion
Exclusion Criteria:
History or presence of clinically significant medical or psychiatric condition ordisease, making the participant unsuitable for enrollment in the opinion of the PIor designee.
History of severe allergic or anaphylactic reactions to any prescription ornon-prescription drug or vaccine.
Participants who took any prescription medications within 14 days of first dosing orwithin 5 half-lives of the drug, whichever is longer.
Participants who took any over the counter (OTC) medication/vitamins/herbalsupplements* in the last 7 days prior to first dosing.
*Exception for occasional use of OTC acetaminophen (paracetamol) 325 to 500 mg every 4 hours not to exceed 3000 mg/day.
- History or diagnosis of a cardiovascular disease condition, including myocardialinfarction, angina, congenital heart disease, cardiomyopathy, hypertension, orhypercholesteremia**.
**Defined as: clinically significant hypercholesteremia with high low-densitylipoprotein (LDL) cholesterol (>/= 160 mg/dL)
- Increased risk for peptic ulcer***
***Defined as: participants with a history of gastric or duodenal ulcer, chronicnon-steroidal anti-inflammatory drug use in the past 3 months, current smokers,alcohol consumption of > 21 alcoholic units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL of wine) or chronic atrophic gastritis,
Female participant with a positive pregnancy test at the screening visit or atbaseline or who is lactating.
Positive urine drug toxicology test (or cotinine or alcohol results) at thescreening visit or check-in.
Has been on a diet incompatible with the on-study diet****, in the opinion of the PIor designee, within the 30 days prior to the first dosing,
****including consumption of grapefruit/Seville orange within 14 days prior to firstdosing,
For Cohorts S2, S3, and S5 only, is known to be intolerant of a high fat/highcalorie diet.
Participants who are unlikely to comply with the study protocol OR those who wouldnot be suitable candidates for participation in the opinion of the investigator.
Participants who donated blood or plasma recently*****
*****Recently defined as within 30 days prior to Day -1, or loss of whole blood ofmore than 500 mL within 30 days prior to Day-1, or receipt of a blood transfusionwithin 1 year of study enrollment.
- Participated in a clinical study involving administration of an investigational drugin the past 30 days (90 days for injectable biological agent) before screening.
Study Design
Study Description
Connect with a study center
Altasciences Inc - Kansas City
Overland Park 4276873, Kansas 4273857 66212
United StatesActive - Recruiting

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