RECRUITING

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

Conditions

Influenza Double-Blind First-in-Human Food-Effect Study Multiple Ascending Dose Nucleoprotein Placebo-Controlled Randomized Safety Single Ascending Dose vnt-101

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A First-in-Human, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VNT-101 Administered Orally to Healthy Adult Participants

Quick Facts

Study Start:2025-09-04

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07169318

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 59 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Provides written informed consent prior to the initiation of any trial procedures. 2. Able to understand and agrees to comply with all planned trial procedures and be available for all study visits. 3. Healthy, adult, male or female (of non-childbearing potential only\), 18-59 years of age, inclusive, at the screening visit. 4. Continuous non-smoker who has not used nicotine-, tobacco-, cannabis-, or cannabidiol-containing products\\* prior to the first dosing based on participant self-reporting. 5. Body mass index (BMI)\>/=18.0 and \</= 30.0 kg/m\^2 at the screening visit. 6. 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, 1. Supine diastolic blood pressure is \>/= 40 mmHg and \</= 90 mmHg at the screening visit. 2. Supine systolic blood pressure is \>/= 90 mmHg and \</= 140 mmHg at the screening visit. 3. Supine heart rate is \>/= 60 bpm and\</= 100 bpm at the screening visit. 4. 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. 5. Estimated creatinine clearance \>/= 80 mL/min based on the Cockroft-Gault equation and creatinine \<1.50 mg/dL at the screening visit. 6. 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. 7. Other clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee. 7. Must agree to refrain from using tanning salons, saunas, sunbathing, or prolonged sun exposure during participation in the study through the follow-up visit. 8. Male participants must agree not to donate sperm during the study and for 90 days following the last administration of Study Product. 9. 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.	1. 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. 2. History of severe allergic or anaphylactic reactions to any prescription or non-prescription drug or vaccine. 3. Participants who took any prescription medications within 14 days of first dosing or within 5 half-lives of the drug, whichever is longer. 4. Participants who took any over the counter (OTC) medication/vitamins/herbal supplements\* in the last 7 days prior to first dosing. 5. History or diagnosis of a cardiovascular disease condition, including myocardial infarction, angina, congenital heart disease, cardiomyopathy, hypertension, or hypercholesteremia\\. 6. Increased risk for peptic ulcer\\\* 7. Female participant with a positive pregnancy test at the screening visit or at baseline or who is lactating. 8. Positive urine drug toxicology test (or cotinine or alcohol results) at the screening visit or check-in. 9. 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, 10. For Cohorts S2, S3, and S5 only, is known to be intolerant of a high fat/high calorie diet. 11. 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. 12. Participants who donated blood or plasma recently\\\\\* 13. Participated in a clinical study involving administration of an investigational drug in the past 30 days (90 days for injectable biological agent) before screening.

Inclusion Criteria

Exclusion Criteria

1. Provides written informed consent prior to the initiation of any trial procedures.
2. Able to understand and agrees to comply with all planned trial procedures and be available for all study visits.
3. Healthy, adult, male or female (of non-childbearing potential only\*), 18-59 years of age, inclusive, at the screening visit.
4. Continuous non-smoker who has not used nicotine-, tobacco-, cannabis-, or cannabidiol-containing products\*\* prior to the first dosing based on participant self-reporting.
5. Body mass index (BMI)\>/=18.0 and \</= 30.0 kg/m\^2 at the screening visit.
6. 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,
1. Supine diastolic blood pressure is \>/= 40 mmHg and \</= 90 mmHg at the screening visit.
2. Supine systolic blood pressure is \>/= 90 mmHg and \</= 140 mmHg at the screening visit.
3. Supine heart rate is \>/= 60 bpm and\</= 100 bpm at the screening visit.
4. 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.
5. Estimated creatinine clearance \>/= 80 mL/min based on the Cockroft-Gault equation and creatinine \<1.50 mg/dL at the screening visit.
6. 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.
7. Other clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.
7. Must agree to refrain from using tanning salons, saunas, sunbathing, or prolonged sun exposure during participation in the study through the follow-up visit.
8. Male participants must agree not to donate sperm during the study and for 90 days following the last administration of Study Product.
9. 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.

1. 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.
2. History of severe allergic or anaphylactic reactions to any prescription or non-prescription drug or vaccine.
3. Participants who took any prescription medications within 14 days of first dosing or within 5 half-lives of the drug, whichever is longer.
4. Participants who took any over the counter (OTC) medication/vitamins/herbal supplements\* in the last 7 days prior to first dosing.
5. History or diagnosis of a cardiovascular disease condition, including myocardial infarction, angina, congenital heart disease, cardiomyopathy, hypertension, or hypercholesteremia\*\*.
6. Increased risk for peptic ulcer\*\*\*
7. Female participant with a positive pregnancy test at the screening visit or at baseline or who is lactating.
8. Positive urine drug toxicology test (or cotinine or alcohol results) at the screening visit or check-in.
9. 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,
10. For Cohorts S2, S3, and S5 only, is known to be intolerant of a high fat/high calorie diet.
11. 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.
12. Participants who donated blood or plasma recently\*\*\*\*\*
13. Participated in a clinical study involving administration of an investigational drug in the past 30 days (90 days for injectable biological agent) before screening.

Contacts and Locations

Study Contact

Nadine Mokhallati

CONTACT

19136961601

NMokhallati@altasciences.com

Study Locations (Sites)

Altasciences Inc - Kansas City

Overland Park, Kansas, 66212

United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-04

Study Completion Date2026-04-01

Study Record Updates

Study Start Date2025-09-04

Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

Double-Blind
First-in-Human
Food-Effect Study
Influenza
Multiple Ascending Dose
Nucleoprotein
Placebo-Controlled
Randomized
Safety
Single Ascending Dose
vnt-101

Additional Relevant MeSH Terms

Influenza