First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT07169318

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

78

Starts

2025-09-16

Expected to finish

2026-11-01

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Altasciences Inc - Kansas City — Overland Park, Kansas, United States (enrolling)

Full record on ClinicalTrials.gov

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