Status:
RECRUITING
First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
Brief Summary
A randomized, double-blind, placebo-controlled Phase 1 study conducted at a single center with approximately 78 healthy adults aged 18-59 years. Part 1 Single Ascending Dose (SAD) will enroll 48 parti...
Detailed Description
This will be a single center, Phase 1, placebo-controlled, randomized, double-blind, integrated sequential Single Ascending Dose (SAD) (with a food-effect cohort) and Multiple Ascending Dose (MAD) stu...
Eligibility Criteria
Inclusion
- 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 be available for all study visits.
- Healthy, adult, male or female (of non-childbearing potential only\*), 18-59 years of age, inclusive, at the screening visit.
- \* Female participants of non-childbearing potential must be either surgically sterile (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 for at least a year, with follicle-stimulating hormone (FSH) in the post-menopausal range at Screening, based on the central laboratory ranges.
- Continuous non-smoker who has not used nicotine-, tobacco-, cannabis-, or cannabidiol-containing products\*\* prior to the first dosing based on participant self-reporting.
- \*\*The period before first dose is at least 3 months for tobacco and associated products 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, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the Principal Investigator (PI) or designee,
- \*\*\*Including the following:
- Supine diastolic blood pressure is \>/= 40 mmHg and \</= 90 mmHg at the screening visit.
- Supine systolic blood pressure is \>/= 90 mmHg and \</= 140 mmHg at the screening visit.
- 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 ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.
- Estimated creatinine clearance \>/= 80 mL/min based on the Cockroft-Gault equation and creatinine \<1.50 mg/dL at the screening visit.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is not greater than 1.1 times the upper limit of normal (ULN), as specified by the testing laboratory.
- Other clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.
- Must agree to refrain from using tanning salons, saunas, sunbathing, or prolonged sun 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 days following 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 product or be vasectomized.
- Acceptable methods of contraception include abstinence from intercourse with a female of childbearing potential or use of male condoms with spermicide or surgical sterilization (vasectomy) of participant at least 26 weeks before the Screening.
Exclusion
- History or presence of clinically significant medical or psychiatric condition or disease, making the participant unsuitable for enrollment in the opinion of the PI or designee.
- History of severe allergic or anaphylactic reactions to any prescription or non-prescription drug or vaccine.
- Participants who took any prescription medications within 14 days of first dosing or within 5 half-lives of the drug, whichever is longer.
- Participants who took any over the counter (OTC) medication/vitamins/herbal supplements\* 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 myocardial infarction, angina, congenital heart disease, cardiomyopathy, hypertension, or hypercholesteremia\*\*.
- \*\*Defined as: clinically significant hypercholesteremia with high low-density lipoprotein (LDL) cholesterol (\>/= 160 mg/dL)
- Increased risk for peptic ulcer\*\*\*
- \*\*\*Defined as: participants with a history of gastric or duodenal ulcer, chronic non-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 at baseline or who is lactating.
- Positive urine drug toxicology test (or cotinine or alcohol results) at the screening visit or check-in.
- Has been on a diet incompatible with the on-study diet\*\*\*\*, in the opinion of the PI or designee, within the 30 days prior to the first dosing,
- \*\*\*\*including consumption of grapefruit/Seville orange within 14 days prior to first dosing,
- For Cohorts S2, S3, and S5 only, is known to be intolerant of a high fat/high calorie diet.
- Participants who are unlikely to comply with the study protocol OR those who would not 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 of more than 500 mL within 30 days prior to Day-1, or receipt of a blood transfusion within 1 year of study enrollment.
- Participated in a clinical study involving administration of an investigational drug in the past 30 days (90 days for injectable biological agent) before screening.
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT07169318
Start Date
September 16 2025
End Date
April 1 2026
Last Update
January 5 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Altasciences Inc - Kansas City
Overland Park, Kansas, United States, 66212