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NCT07169318 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT07169318 is a Phase 1 study of Influenza that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 78 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07169318, a Phase 1 study of Influenza, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- OTHER Placebo for VNT-101
- DRUG VNT-101
Study Locations (1)
Kansas
- Altasciences Inc - Kansas City - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2025-09-16 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07169318
The ClinicalTrials.gov registry entry for NCT07169318 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Placebo for VNT-101 is the first listed.
NCT07169318 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT07169318 about?
NCT07169318 is a clinical study titled "First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics". 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 un...
What is the current status of trial NCT07169318?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2025-09-16. Estimated completion is 2026-04-01.
What conditions does trial NCT07169318 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT07169318?
The interventions under investigation include: Placebo for VNT-101 (OTHER), VNT-101 (DRUG).
Who is sponsoring clinical trial NCT07169318?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07169318 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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