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.
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.
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.
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Treatment groupsSee each treatment group below.