VNT-101 for Safety and Tolerability Study

Overseen By Nadine Mokhallati

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Prescription drugs, OTC meds

Disqualifiers: Cardiovascular disease, Peptic ulcer, others

Compensation: Varies

Number of Visits: 1

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing the safety and tolerability of a new treatment called VNT-101. Researchers aim to observe how healthy adults respond to both single and multiple oral doses of this drug. The trial includes different groups, with some receiving VNT-101 and others a placebo, to assess the drug's effects under various conditions. Ideal participants are healthy adults who do not smoke, have no significant medical history, and maintain a stable lifestyle without recent use of tobacco or cannabis products. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription medications at least 14 days before the trial starts, and any over-the-counter medications, vitamins, or herbal supplements 7 days before, except for occasional use of acetaminophen.

Is there any evidence suggesting that VNT-101 is likely to be safe for humans?

Research has shown that VNT-101 is currently being tested for safety in humans. This treatment remains in the early stages of research, so limited information is available about its safety. As this marks the first human trial, researchers are proceeding cautiously, starting with low doses to monitor for side effects.

Since VNT-101 is in an early testing phase, it has not been approved for any conditions. Consequently, no data from widespread use exists to confirm its safety. The research team will closely monitor for any issues and adjust doses carefully to ensure participant safety.

For those considering joining a trial, it is important to know that early-phase studies like this one are controlled and monitored to find the right balance between safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about VNT-101 because it introduces a novel approach with its unique mechanism of action. Unlike current treatment options that might target symptoms more generally, VNT-101 works by specifically interacting with targeted pathways in the body, potentially offering a more precise and effective treatment. Additionally, VNT-101 is administered orally, which could make it more convenient and accessible for patients compared to other treatments that require injections or more invasive methods. The potential for quicker results and fewer side effects also adds to the enthusiasm surrounding its development.

What evidence suggests that VNT-101 could be effective?

Research shows that VNT-101 could be a promising treatment for the flu. Studies have found that it can reduce the risk of flu infection by 58% to 76%, depending on the dose. The drug stops the influenza A virus from spreading in the body. Early lab tests showed effectiveness even in small amounts, suggesting strong potential. Although human studies provide limited information, these early results are encouraging. Participants in this trial will receive different doses of VNT-101 to assess its safety and tolerability. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-59 who want to participate in a study testing the safety of a new drug, VNT-101, which could potentially treat flu. Participants must be in good health and willing to take either the drug or a placebo.

Inclusion Criteria

Able to understand and agrees to comply with all planned trial procedures and be available for all study visits

Body mass index (BMI)>=18.0 and <= 30.0 kg/m^2 at the screening visit

I am a healthy adult between 18-59 years old and cannot become pregnant.

Exclusion Criteria

For Cohorts S2, S3, and S5 only, is known to be intolerant of a high fat/high calorie diet

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of VNT-101 or placebo under fasting or fed conditions

6 cohorts, each with a single dose

1 visit per cohort

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of VNT-101 or placebo under fasting conditions

6 days per cohort

Daily visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• VNT-101

Trial Overview The study tests VNT-101's safety when taken once (single dose) or over several days (multiple doses). It's randomized and double-blind, meaning neither researchers nor participants know who gets the real drug versus placebo. The trial has two parts: one for single doses under different conditions and another for multiple doses.

How Is the Trial Designed?

Group I: Part 2 (MAD) Cohort M3 Arm 1 Experimental Treatment 1 Intervention

Following Single Ascending Dose (SAD) safety and PK data review by the Safety Monitoring Committee (SMC), healthy adult participants \>/= 18 to 59 years will receive Multiple Ascending Dose (MAD) of 750 mg of VNT-101 twice daily (BID) on Days 1 through 5 and 1500mg of VNT-101 once daily (QD) on Day 6 administered orally with approximately 240ml of water under fasting conditions. N=8

Group II: Part 2 (MAD) Cohort M2 Arm 1 Experimental Treatment 1 Intervention

Following Single Ascending Dose (SAD) safety and PK data review by the Safety Monitoring Committee (SMC), healthy adult participants \>/= 18 to 59 years will receive Multiple Ascending Dose (MAD) of 500 mg of VNT-101 twice daily (BID) on Days 1 through 5 and 1000mg of VNT-101 once daily (QD) on Day 6 administered orally with approximately 240ml of water under fasting conditions. N=8

Group III: Part 2 (MAD) Cohort M1 Arm 1 Experimental Treatment 1 Intervention

Following Single Ascending Dose (SAD) safety and Pharmacokinetics (PK) data review by the Safety Monitoring Committee (SMC), healthy adult participants \>/= 18 to 59 years will receive Multiple Ascending Dose (MAD) of 250 mg of VNT-101 twice daily (BID) on Days 1 through 5 and 500mg of VNT-101 once daily (QD) on Day 6 administered orally with approximately 240ml of water under fasting conditions. N=8

Group IV: Part 1 (SAD) Cohort S6 Arm 1 Experimental Treatment 1 Intervention

Healthy adult participants \>/= 18 to 59 years will receive a Single Ascending Dose (SAD) of VNT-101 at 1500 mg administered orally with approximately 240ml of water under fasting conditions. N=6

Group V: Part 1 (SAD) Cohort S5 Arm 1 Experimental Treatment 1 Intervention

Healthy adult participants \>/= 18 to 59 years from Cohort S3 will receive a Single Ascending Dose (SAD) of VNT-101 at 500 mg administered orally with approximately 240ml of water under fed (high-fat meal) conditions. N=6

Group VI: Part 1 (SAD) Cohort S4 Arm 1 Experimental Treatment 1 Intervention

Healthy adult participants \>/= 18 to 59 years will receive a Single Ascending Dose (SAD) of VNT-101 at 1000 mg administered orally with approximately 240ml of water under fasting conditions. N=6

Group VII: Part 1 (SAD) Cohort S3 Arm 1 Experimental Treatment 1 Intervention

Healthy adult participants \>/= 18 to 59 years will receive a Single Ascending Dose (SAD) of VNT-101 at 500 mg administered orally with approximately 240ml of water under fasting conditions. N=6

Group VIII: Part 1 (SAD) Cohort S2 Arm 1 Experimental Treatment 1 Intervention

Healthy adult participants \>/= 18 to 59 years will receive Single Ascending Dose (SAD) of VNT-101 at 250 mg administered orally with approximately 240ml of water under fasting conditions. N=6

Group IX: Part 1 (SAD) Cohort S1 Arm 1 Experimental Treatment 1 Intervention

Healthy adult participants \>/= 18 to 59 years will receive a Single Ascending Dose (SAD) of VNT-101 at 100 mg administered orally with approximately 240ml of water under fasting conditions. N=6

Group X: Part 1 (SAD) Cohort S1 Arm 2 Placebo Group 1 Intervention

Healthy adult participants \>/= 18 to 59 years will receive a Single Ascending Dose (SAD) of Placebo for VNT-101 at 100mg administered orally with approximately 240ml of water under fasting conditions. N=2

Group XI: Part 1 (SAD) Cohort S2 Arm 2 Placebo Group 1 Intervention

Healthy adult participants \>/= 18 to 59 years will receive a Single Ascending Dose (SAD) of Placebo for VNT-101 at 250mg administered orally with approximately 240ml of water under fasting conditions. N=2

Group XII: Part 1 (SAD) Cohort S4 Arm 2 Placebo Group 1 Intervention

Healthy adult participants \>/= 18 to 59 years will receive Single Ascending Dose (SAD) of Placebo for VNT-101 at 1000mg administered orally with approximately 240ml of water under fasting conditions. N=2

Group XIII: Part 2 (MAD) Cohort M1 Arm 2 Placebo Group 1 Intervention

Following Single Ascending Dose (SAD) safety and Pharmacokinetics (PK) data review by the Safety Monitoring Committee (SMC), healthy adult participants \>/= 18 to 59 years will receive Multiple Ascending Dose (MAD) of 250 mg of Placebo for VNT-101 twice daily (BID) on Days 1 through 5 and 500mg of Placebo for VNT-101 once daily (QD) on Day 6 administered orally with approximately 240ml of water under fasting conditions. N=2

Group XIV: Part 1 (SAD) Cohort S3 Arm 2 Placebo Group 1 Intervention

Healthy adult participants \>/= 18 to 59 years will receive a Single Ascending Dose (SAD) of Placebo for VNT-101 at 500mg administered orally with approximately 240ml of water under fasting conditions. N=2

Group XV: Part 1 (SAD) Cohort S5 Arm 2 Placebo Group 1 Intervention

Healthy adult participants \>/= 18 to 59 years from Cohort 3 will receive a Single Ascending Dose (SAD) of Placebo for VNT-101 at 500mg administered orally with approximately 240ml of water under fed (high-fat meal) conditions. N=2

Group XVI: Part 1 (SAD) Cohort S6 Arm 2 Placebo Group 1 Intervention

Healthy adult participants \>/= 18 to 59 years will receive a Single Ascending Dose (SAD) of Placebo for VNT-101 at 1500mg administered orally with approximately 240ml of water under fasting conditions. N=2

Group XVII: Part 2 (MAD) Cohort M2 Arm 2 Placebo Group 1 Intervention

Following Single Ascending Dose (SAD) safety and Pharmacokinetics (PK) data review by the Safety Monitoring Committee (SMC), healthy adult participants \>/= 18 to 59 years will receive Multiple Ascending Dose (MAD) of 500 mg of Placebo for VNT-101 twice daily (BID) on Days 1 through 5 and 1000mg of Placebo for VNT-101 once daily (QD) on Day 6 administered orally with approximately 240ml of water under fasting conditions. N=2

Group XVIII: Part 2 (MAD) Cohort M3 Arm 2 Placebo Group 1 Intervention

Following Single Ascending Dose (SAD) safety and Pharmacokinetics (PK) data review by the Safety Monitoring Committee (SMC), healthy adult participants \>/= 18 to 59 years will receive Multiple Ascending Dose (MAD) of 750 mg of Placebo for VNT-101 twice daily (BID) on Days 1 through 5 and 1500mg of Placebo for VNT-101 once daily (QD) on Day 6 administered orally with approximately 240ml of water under fasting conditions. N=2

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07169318?term=TREATMENt

First-in-Human Study of VNT-101: Safety, Tolerability, and ... Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07169318/first-in-human-study-of-vnt-101-safety-tolerability-and-pharmacokinetics

First-in-Human Study of VNT-101: Safety, Tolerability, and ... A randomized, double-blind, placebo-controlled Phase 1 study conducted at a single center with approximately 78 healthy adults aged 18-59 ...

3. synapse.patsnap.com synapse.patsnap.com/drug/c2d5fcf096b2421c8feb9a2568ac88ce

VNT-101 - Drug Targets, Indications, Patents ... Tolerability, and Pharmacokinetics of VNT-101 Administered Orally to Healthy Adult Participants. 100 Clinical Results associated with VNT-101.

4. academic.oup.com academic.oup.com/jid/article/232/Supplement_3/S169/8287899

Introduction and Update: Advances in Influenza Therapeutics The topline results of this trial indicated statistically significant, dose-related relative risk reductions in influenza illness of 58% to 76% ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40700440/

Discovery and Optimization of a Novel Series of Influenza ... Medicinal chemistry optimization efforts resulted in the identification of compound 20 (VNT-101) as a potent IAV inhibitor with low nM activity ...

6. ctv.veeva.com ctv.veeva.com/study/first-in-human-study-of-vnt-101-safety-tolerability-and-pharmacokinetics

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

7. withpower.com withpower.com/trial/phase-1-influenza-human-8-2025-e8c07

VNT-101 for Safety and Tolerability Study 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.