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Study identifier: NCT07169318 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

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

PhasePhase 1
Planned participants78
Who can joinAll sexes, 18 Years to 59 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Nadine Mokhallati  ·  19136961601  ·  NMokhallati@altasciences.com

Always discuss trial participation with your own doctor first.

Locations (1)

Altasciences Inc - Kansas CityOverland Park, Kansas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07169318