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RECRUITING
NCT07169318
PHASE1

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

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

View on ClinicalTrials.gov

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 (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

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2025-09-16

Completion Date

2026-04-01

Last Updated

2026-03-20

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Placebo for VNT-101

Capsules will be size 00 and filled with microcrystalline cellulose

DRUG

VNT-101

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.

Locations (1)

Altasciences Inc - Kansas City

Overland Park, Kansas, United States