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
National Institute of Allergy and Infectious Diseases (NIAID)
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.
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.…
Eligibility
- Age range
- 18–59 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion 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. \* 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 lea…
Interventions
- OtherPlacebo for VNT-101
Capsules will be size 00 and filled with microcrystalline cellulose
- DrugVNT-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.
Location
- Altasciences Inc - Kansas CityOverland Park, Kansas