Actively Recruiting
First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-11
78
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 participants into six cohorts (S1-S6) to receive single oral doses of VNT-101 (100-1500 mg) or placebo under fasting or fed (S5 only) conditions. Part 2 Multiple Ascending Dose (MAD) will enroll 30 participants into three cohorts (M1-M3) to receive multiple oral doses of VNT-101 (250-750 mg BID Days 1-5, QD Day 6) or placebo under fasting conditions. Dose escalation in both parts will proceed after Protocol Safety Review Team (PSRT) review. The primary objective for Part 1 is to evaluate the safety and tolerability of single ascending oral (SAD) doses of VNT-101 in healthy adult participants under either fasting or fed conditions. The primary objective for part 2 is to evaluate the safety and tolerability of multiple ascending oral (MAD) doses of VNT-101 in healthy adult participants.
CONDITIONS
Official Title
First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provides written informed consent before any trial procedures
- Able to understand and comply with all planned trial procedures and available for all visits
- Healthy adult male or female (non-childbearing potential) aged 18 to 59 years at screening
- Female participants must be surgically sterile or post-menopausal as defined
- Non-smoker without use of nicotine, tobacco, cannabis, or cannabidiol products for at least 3 months (tobacco) or 60 days (cannabis) before first dosing
- Body mass index between 18.0 and 30.0 kg/m^2 at screening
- Medically healthy with no significant medical history, normal physical exam, labs, vital signs, and ECG as assessed by investigator
- Supine diastolic blood pressure between 40 and 90 mmHg
- Supine systolic blood pressure between 90 and 140 mmHg
- Supine heart rate between 60 and 100 bpm
- QTcF interval ≤460 msec for males and ≤470 msec for females with normal ECG findings
- Estimated creatinine clearance ≥80 mL/min and creatinine <1.50 mg/dL
- ALT or AST not greater than 1.1 times the upper limit of normal
- Other clinical labs within normal range unless deemed not significant
- Agree to avoid tanning salons, saunas, sunbathing, or prolonged sun exposure during study and follow-up
- Male participants must agree not to donate sperm during study and for 90 days after last dose
- Male participants must use medically accepted contraception during study and for 30 days after last dose or be vasectomized
You will not qualify if you...
- History or presence of significant medical or psychiatric conditions making participant unsuitable
- History of severe allergic or anaphylactic reactions to drugs or vaccines
- Use of prescription medications within 14 days or 5 half-lives before first dosing
- Use of OTC medications, vitamins, or herbal supplements within 7 days before dosing (except occasional acetaminophen)
- History or diagnosis of cardiovascular disease including myocardial infarction, angina, congenital heart disease, cardiomyopathy, hypertension, or high LDL cholesterol (≥160 mg/dL)
- Increased risk for peptic ulcer including history of ulcers, chronic NSAID use in past 3 months, current smokers, heavy alcohol use (>21 units/week), or chronic atrophic gastritis
- Female participants who are pregnant, lactating, or have positive pregnancy test at screening or baseline
- Positive urine drug, cotinine, or alcohol test at screening or check-in
- Incompatible diet within 30 days prior to dosing including grapefruit or Seville orange consumption within 14 days
- Known intolerance to high fat/high calorie diet for certain cohorts
- Unlikely to comply with study protocol or unsuitable as judged by investigator
- Recent blood or plasma donation within 30 days or blood transfusion within 1 year
- Participation in investigational drug trial within 30 days (90 days for injectable biologics) before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Altasciences Inc - Kansas City
Overland Park, Kansas, United States, 66212
Actively Recruiting
Research Team
N
Nadine Mokhallati
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
18
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