InfluenzaPhase 1NCT07169318
First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics
A Phase 1 study testing VNT-101 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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 participants into six cohorts (S1-S6) to receive single oral doses of VNT-101 (100-1500 mg) or placebo under fasting or fed… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VNT-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to 1 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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**.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Altasciences Inc - Kansas City
Overland Park, Kansas, 66212
About this study
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
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.
Read the 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) study. The study will be divided into two parts, Part 1: SAD cohorts, with a cohort for food effect evaluation and Part 2: MAD cohorts. Part 1 will be completed sequentially with Protocol Safety Review Team (PSRT) reviews before advancing to the next higher dose. An interim analysis will be performed and reviewed by the SMC before the start of Part 2 and complete ascending dose levels sequentially.
Part 1 will consist of 6 cohorts (1 cohort per dose level). Approximately 48 healthy adult participants in 6 cohorts (S1 to S6) are planned for sequential randomization and evaluation. Each cohort will include 8 participants (6 participants will be administered the study product VNT-101 and 2 matching placebo). SAD doses planned of VNT-101 range from a starting dose of 100 mg up to a highest dose of 1500 mg. Cohorts S1, S2, S3, S4, and S6 will be dosed in a double-blinded manner in a fasting state, whereas Cohort S5 will be dosed in a blinded manner in the fed state (high-fat meal) and will consist of the 8 participants who participated in Cohort S3, showing AUC and Cmax exposures at least 3-fold less than the cohort dose escalation criteria for exposure limit for AUD and Cmax. If AUC or Cmax are within 3-fold of the halting limit, then Cohort S5 may utilize the lower dose of 250mg evaluated in participants from Cohort S2, who were given a lower dose of 250mg in the fasted state, unless the PSRT decides a different cohort (Cohort S2) should return based on blinded Pharmacokinetics (PK) results. 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 secondary objective of part 1 is to characterize the PK profile of VNT-101 in plasma after single oral dose of VNT-101 in fasted healthy adult participants and one dose in fed healthy adult participants.
In Part 2, approximately 30 healthy adult participants in 3 cohorts (Cohorts M1 to M3) of 10 participants each (8 active and 2 placebo) are planned for sequential randomization and evaluation. Cohorts will be dosed sequentially in an ascending fashion. In each cohort, participants will receive under fasting conditions 11 oral doses of VNT-101 or placebo twice daily (BID) for 5 days with an additional dose being administered on the morning of Day 6. 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. The Secondary objectives are 1) To characterize the PK profile of VNT-101 in plasma after multiple oral doses of VNT-101 in healthy adult participants and 2) To characterize the PK profile of VNT-101 in urine after multiple oral doses of VNT-101 in healthy adult participants.
- Conditions
- Influenza
- Being tested
- Placebo for VNT-101, VNT-101
- Keywords
- Double-Blind, First-in-Human, Food-Effect Study, Influenza, Multiple Ascending Dose, Nucleoprotein, Placebo-Controlled, Randomized, Safety, Single Ascending Dose, vnt-101
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo for VNT-101Other
Capsules will be size 00 and filled with microcrystalline cellulose
VNT-101Drug
VNT-101 is an orally bioavailable, direct-acting antiviral with a novel mechanism of action - inhibiting oligomerization of the influenza nucleoprotein (NP) and thereby inhibiting viral ribonucleic acid (RNA) synthesis.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (SAD) Cohort S1 Arm 1 | Experimental | 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 Receives: Drug: VNT-101 |
| Part 1 (SAD) Cohort S1 Arm 2 | Placebo comparator | 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 Receives: Other: Placebo for VNT-101 |
| Part 1 (SAD) Cohort S2 Arm 1 | Experimental | 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 Receives: Drug: VNT-101 |
| Part 1 (SAD) Cohort S2 Arm 2 | Placebo comparator | 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 Receives: Other: Placebo for VNT-101 |
| Part 1 (SAD) Cohort S3 Arm 1 | Experimental | 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 Receives: Drug: VNT-101 |
| Part 1 (SAD) Cohort S3 Arm 2 | Placebo comparator | 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 Receives: Other: Placebo for VNT-101 |
| Part 1 (SAD) Cohort S4 Arm 1 | Experimental | 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 Receives: Drug: VNT-101 |
| Part 1 (SAD) Cohort S4 Arm 2 | Placebo comparator | 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 Receives: Other: Placebo for VNT-101 |
| Part 1 (SAD) Cohort S5 Arm 1 | Experimental | 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 Receives: Drug: VNT-101 |
| Part 1 (SAD) Cohort S5 Arm 2 | Placebo comparator | 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 Receives: Other: Placebo for VNT-101 |
| Part 1 (SAD) Cohort S6 Arm 1 | Experimental | 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 Receives: Drug: VNT-101 |
| Part 1 (SAD) Cohort S6 Arm 2 | Placebo comparator | 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 Receives: Other: Placebo for VNT-101 |
| Part 2 (MAD) Cohort M1 Arm 1 | Experimental | 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 Receives: Drug: VNT-101 |
| Part 2 (MAD) Cohort M1 Arm 2 | Placebo comparator | 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 Receives: Other: Placebo for VNT-101 |
| Part 2 (MAD) Cohort M2 Arm 1 | Experimental | 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 Receives: Drug: VNT-101 |
| Part 2 (MAD) Cohort M2 Arm 2 | Placebo comparator | 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 Receives: Other: Placebo for VNT-101 |
| Part 2 (MAD) Cohort M3 Arm 1 | Experimental | 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 Receives: Drug: VNT-101 |
| Part 2 (MAD) Cohort M3 Arm 2 | Placebo comparator | 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 Receives: Other: Placebo for VNT-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade change from baseline in any 12-lead ECG reading
Measured: Day 1 through Day 13
Grade change from baseline in any clinical laboratory parameter
Measured: Day 1 through Day 13
Grade change from baseline in any vital sign
Measured: Day 1 through Day 13
Incidence of Treatment Emergent Adverse Events (TEAEs)
Measured: Day 1 through Day 13
Secondary outcomes (23)
Accumulation ratio based on area under the concentration curve (RA_AUC) in plasma
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Accumulation ratio based on Cmax (RA_Cmax) in plasma
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Amount of drug excreted unchanged between t1 and t2 (Aet1-t2,ss) in urine
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Apparent volume of distribution at terminal phase (VZ/F) in plasma
Single Ascending Dose (SAD) cohorts only.
Measured: Day 1 through Day 4
Apparent volume of distribution at terminal phase at a steady state (Vz,ss/F) in plasma
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Area under the concentration curve from time 0 to 12 hours (AUC0-12) in plasma
Measured: Day 1 through Day 9
Area under the concentration curve from time 0 to infinity (AUC0-infinity) in plasma
Single Ascending Dose (SAD) cohorts only.
Measured: Day 1 through Day 4
Area under the concentration curve from time 0 to time t (AUC0-t) in plasma
Measured: Day 1 through Day 9
Area under the concentration versus time curve over the dosing interval, tau (AUCtau) in plasma
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Calculated average concentration (Cavg) in plasma
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Change from baseline in clearance at a steady state (CLss/F) in plasma
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Clearance (CL/F) in plasma
Single Ascending Dose (SAD) cohorts only.
Measured: Day 1 through Day 4
Cumulative amount of drug excreted unchanged (CumAess) in urine
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Cumulative fraction of drug excreted unchanged (CumFess) in urine
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Elimination half-life (t1/2) in plasma
Measured: Day 1 through Day 9
Fraction of drug excreted unchanged between t1 and t2 (Fet1-t2,ss) in urine
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Maximum observed concentration (Cmax) in plasma
Measured: Day 1 through Day 9
Maximum observed concentration (Ctrough) in plasma
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Maximum observed plasma concentration at a steady state (Cmax,ss) in plasma
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Minimum observed plasma concentration at a steady state (Cmin,ss) in plasma
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Renal clearance at steady state (CLrss)
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Terminal elimination rate constant (Kel) in plasma
Measured: Day 1 through Day 9
Time of observed maximum concentration (Tmax) at a steady state (Tmax,ss) in plasma
Multiple Ascending Dose (MAD) cohorts only.
Measured: Through Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start16 Sep 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169318
- Sponsor's protocol ID
- 23-0024
- Other IDs
- 75N93022D00015
- Status last verified
- 6 May 2026
- First submitted
- 3 Jul 2025
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07169318
- Acronym / sponsor ID
- 23-0024
- Conditions
- Influenza
- Keywords
- Double-Blind, First-in-Human, Food-Effect Study, Influenza, Multiple Ascending Dose, Nucleoprotein, Placebo-Controlled, Randomized
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) study. The study will be divided into two parts, Part 1: SAD cohorts, with a cohort for food effect evaluation and Part 2: MAD cohorts. Part 1 will be completed sequentially with Protocol Safety Review Team (PSRT) reviews before advancing to the next higher dose. An interim analysis will be performed and reviewed by the SMC before the start of Part 2 and complete ascending dose levels sequentially.
Part 1 will consist of 6 cohorts (1 cohort per dose level). Approximately 48 healthy adult participants in 6 cohorts (S1 to S6) are planned for sequential randomization and evaluation. Each cohort will include 8 participants (6 participants will be administered the study product VNT-101 and 2 matching placebo). SAD doses planned of VNT-101 range from a starting dose of 100 mg up to a highest dose of 1500 mg. Cohorts S1, S2, S3, S4, and S6 will be dosed in a double-blinded manner in a fasting state, whereas Cohort S5 will be dosed in a blinded manner in the fed state (high-fat meal) and will consist of the 8 participants who participated in Cohort S3, showing AUC and Cmax exposures at least 3-fold less than the cohort dose escalation criteria for exposure limit for AUD and Cmax. If AUC or Cmax are within 3-fold of the halting limit, then Cohort S5 may utilize the lower dose of 250mg evaluated in participants from Cohort S2, who were given a lower dose of 250mg in the fasted state, unless the PSRT decides a different cohort (Cohort S2) should return based on blinded Pharmacokinetics (PK) results. 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 secondary objective of part 1 is to characterize the PK profile of VNT-101 in plasma after single oral dose of VNT-101 in fasted healthy adult participants and one dose in fed healthy adult participants.
In Part 2, approximately 30 healthy adult participants in 3 cohorts (Cohorts M1 to M3) of 10 participants each (8 active and 2 placebo) are planned for sequential randomization and evaluation. Cohorts will be dosed sequentially in an ascending fashion. In each cohort, participants will receive under fasting conditions 11 oral doses of VNT-101 or placebo twice daily (BID) for 5 days with an additional dose being administered on the morning of Day 6. 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. The Secondary objectives are 1) To characterize the PK profile of VNT-101 in plasma after multiple oral doses of VNT-101 in healthy adult participants and 2) To characterize the PK profile of VNT-101 in urine after multiple oral doses of VNT-101 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Part 1 (SAD) Cohort S1 Arm 1 | Experimental | Drug: VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S1 Arm 2 | Placebo comparator | Other: Placebo for VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S2 Arm 1 | Experimental | Drug: VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S2 Arm 2 | Placebo comparator | Other: Placebo for VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S3 Arm 1 | Experimental | Drug: VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S3 Arm 2 | Placebo comparator | Other: Placebo for VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S4 Arm 1 | Experimental | Drug: VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S4 Arm 2 | Placebo comparator | Other: Placebo for VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S5 Arm 1 | Experimental | Drug: VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S5 Arm 2 | Placebo comparator | Other: Placebo for VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S6 Arm 1 | Experimental | Drug: VNT-101Healthy 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 |
| Part 1 (SAD) Cohort S6 Arm 2 | Placebo comparator | Other: Placebo for VNT-101Healthy 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 |
| Part 2 (MAD) Cohort M1 Arm 1 | Experimental | Drug: VNT-101Following 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 |
| Part 2 (MAD) Cohort M1 Arm 2 | Placebo comparator | Other: Placebo for VNT-101Following 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 |
| Part 2 (MAD) Cohort M2 Arm 1 | Experimental | Drug: VNT-101Following 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 |
| Part 2 (MAD) Cohort M2 Arm 2 | Placebo comparator | Other: Placebo for VNT-101Following 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 |
| Part 2 (MAD) Cohort M3 Arm 1 | Experimental | Drug: VNT-101Following 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 |
| Part 2 (MAD) Cohort M3 Arm 2 | Placebo comparator | Other: Placebo for VNT-101Following 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 may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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.
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo for VNT-101Capsules will be size 00 and filled with microcrystalline cellulose | Other | Part 1 (SAD) Cohort S1 Arm 2, Part 1 (SAD) Cohort S2 Arm 2, Part 1 (SAD) Cohort S3 Arm 2, Part 1 (SAD) Cohort S4 Arm 2, Part 1 (SAD) Cohort S5 Arm 2, Part 1 (SAD) Cohort S6 Arm 2, Part 2 (MAD) Cohort M1 Arm 2, Part 2 (MAD) Cohort M2 Arm 2, Part 2 (MAD) Cohort M3 Arm 2 |
| VNT-101VNT-101 is an orally bioavailable, direct-acting antiviral with a novel mechanism of action - inhibiting oligomerization of the influenza nucleoprotein (NP) and thereby inhibiting viral ribonucleic acid (RNA) synthesis. | Drug | Part 1 (SAD) Cohort S1 Arm 1, Part 1 (SAD) Cohort S2 Arm 1, Part 1 (SAD) Cohort S3 Arm 1, Part 1 (SAD) Cohort S4 Arm 1, Part 1 (SAD) Cohort S5 Arm 1, Part 1 (SAD) Cohort S6 Arm 1, Part 2 (MAD) Cohort M1 Arm 1, Part 2 (MAD) Cohort M2 Arm 1, Part 2 (MAD) Cohort M3 Arm 1 |
Primary outcome
Grade change from baseline in any 12-lead ECG reading
Time frame: Day 1 through Day 13
Grade change from baseline in any clinical laboratory parameter
Time frame: Day 1 through Day 13
Grade change from baseline in any vital sign
Time frame: Day 1 through Day 13
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 13
23 secondary outcomes
Accumulation ratio based on area under the concentration curve (RA_AUC) in plasma
Time frame: Through Day 9
Accumulation ratio based on Cmax (RA_Cmax) in plasma
Time frame: Through Day 9
Amount of drug excreted unchanged between t1 and t2 (Aet1-t2,ss) in urine
Time frame: Through Day 9
Apparent volume of distribution at terminal phase (VZ/F) in plasma
Time frame: Day 1 through Day 4
Apparent volume of distribution at terminal phase at a steady state (Vz,ss/F) in plasma
Time frame: Through Day 9
Area under the concentration curve from time 0 to 12 hours (AUC0-12) in plasma
Time frame: Day 1 through Day 9
Area under the concentration curve from time 0 to infinity (AUC0-infinity) in plasma
Time frame: Day 1 through Day 4
Area under the concentration curve from time 0 to time t (AUC0-t) in plasma
Time frame: Day 1 through Day 9
Area under the concentration versus time curve over the dosing interval, tau (AUCtau) in plasma
Time frame: Through Day 9
Calculated average concentration (Cavg) in plasma
Time frame: Through Day 9
Change from baseline in clearance at a steady state (CLss/F) in plasma
Time frame: Through Day 9
Clearance (CL/F) in plasma
Time frame: Day 1 through Day 4
Cumulative amount of drug excreted unchanged (CumAess) in urine
Time frame: Through Day 9
Cumulative fraction of drug excreted unchanged (CumFess) in urine
Time frame: Through Day 9
Elimination half-life (t1/2) in plasma
Time frame: Day 1 through Day 9
Fraction of drug excreted unchanged between t1 and t2 (Fet1-t2,ss) in urine
Time frame: Through Day 9
Maximum observed concentration (Cmax) in plasma
Time frame: Day 1 through Day 9
Maximum observed concentration (Ctrough) in plasma
Time frame: Through Day 9
Maximum observed plasma concentration at a steady state (Cmax,ss) in plasma
Time frame: Through Day 9
Minimum observed plasma concentration at a steady state (Cmin,ss) in plasma
Time frame: Through Day 9
Renal clearance at steady state (CLrss)
Time frame: Through Day 9
Terminal elimination rate constant (Kel) in plasma
Time frame: Day 1 through Day 9
Time of observed maximum concentration (Tmax) at a steady state (Tmax,ss) in plasma
Time frame: Through Day 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VNT-101 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine Mokhallati (19136961601, NMokhallati@altasciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade change from baseline in any 12-lead ECG reading (time frame: Day 1 through Day 13). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.