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

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07169318
Phase
PHASE1
Status
Recruiting
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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - 59 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo for VNT-101 — OTHER
    Capsules will be size 00 and filled with microcrystalline cellulose
  • VNT-101 — DRUG
    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 Details

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 Dates

Start date
Sep 16, 2025
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (SAD) Cohort S1 Arm 1
    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
  • Placebo Comparator: Part 1 (SAD) Cohort S1 Arm 2
    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
  • Experimental: Part 1 (SAD) Cohort S2 Arm 1
    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
  • Placebo Comparator: Part 1 (SAD) Cohort S2 Arm 2
    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
  • Experimental: Part 1 (SAD) Cohort S3 Arm 1
    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
  • Placebo Comparator: Part 1 (SAD) Cohort S3 Arm 2
    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
  • Experimental: Part 1 (SAD) Cohort S4 Arm 1
    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
  • Placebo Comparator: Part 1 (SAD) Cohort S4 Arm 2
    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
  • Experimental: Part 1 (SAD) Cohort S5 Arm 1
    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
  • Placebo Comparator: Part 1 (SAD) Cohort S5 Arm 2
    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
  • Experimental: Part 1 (SAD) Cohort S6 Arm 1
    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
  • Placebo Comparator: Part 1 (SAD) Cohort S6 Arm 2
    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
  • Experimental: Part 2 (MAD) Cohort M1 Arm 1
    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
  • Placebo Comparator: Part 2 (MAD) Cohort M1 Arm 2
    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
  • Experimental: Part 2 (MAD) Cohort M2 Arm 1
    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
  • Placebo Comparator: Part 2 (MAD) Cohort M2 Arm 2
    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
  • Experimental: Part 2 (MAD) Cohort M3 Arm 1
    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
  • Placebo Comparator: Part 2 (MAD) Cohort M3 Arm 2
    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

Primary Outcome Measure

Grade change from baseline in any 12-lead ECG reading [ Time Frame: Day 1 through Day 13 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Altasciences Inc - Kansas CityOverland ParkKansas66212-

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