Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT07169318
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-09-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Part 1 will consist of 6 cohorts (1 cohort per dose level). Approximately 48 healthy adult participants in 6 cohorts (S1 to S6) are planned for sequential randomization and evaluation. Each cohort will include 8 participants (6 participants will be administered the study product VNT-101 and 2 matching placebo). SAD doses planned of VNT-101 range from a starting dose of 100 mg up to a highest dose of 1500 mg. Cohorts S1, S2, S3, S4, and S6 will be dosed in a double-blinded manner in a fasting state, whereas Cohort S5 will be dosed in a blinded manner in the fed state (high-fat meal) and will consist of the 8 participants who participated in Cohort S3, showing AUC and Cmax exposures at least 3-fold less than the cohort dose escalation criteria for exposure limit for AUD and Cmax. If AUC or Cmax are within 3-fold of the halting limit, then Cohort S5 may utilize the lower dose of 250mg evaluated in participants from Cohort S2, who were given a lower dose of 250mg in the fasted state, unless the PSRT decides a different cohort (Cohort S2) should return based on blinded Pharmacokinetics (PK) results. 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 secondary objective of part 1 is to characterize the PK profile of VNT-101 in plasma after single oral dose of VNT-101 in fasted healthy adult participants and one dose in fed healthy adult participants.
In Part 2, approximately 30 healthy adult participants in 3 cohorts (Cohorts M1 to M3) of 10 participants each (8 active and 2 placebo) are planned for sequential randomization and evaluation. Cohorts will be dosed sequentially in an ascending fashion. In each cohort, participants will receive under fasting conditions 11 oral doses of VNT-101 or placebo twice daily (BID) for 5 days with an additional dose being administered on the morning of Day 6. 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. The Secondary objectives are 1) To characterize the PK profile of VNT-101 in plasma after multiple oral doses of VNT-101 in healthy adult participants and 2) To characterize the PK profile of VNT-101 in urine after multiple oral doses of VNT-101 in healthy adult participants.
Part 1 will consist of 6 cohorts (1 cohort per dose level). Approximately 48 healthy adult participants in 6 cohorts (S1 to S6) are planned for sequential randomization and evaluation. Each cohort will include 8 participants (6 participants will be administered the study product VNT-101 and 2 matching placebo). SAD doses planned of VNT-101 range from a starting dose of 100 mg up to a highest dose of 1500 mg. Cohorts S1, S2, S3, S4, and S6 will be dosed in a double-blinded manner in a fasting state, whereas Cohort S5 will be dosed in a blinded manner in the fed state (high-fat meal) and will consist of the 8 participants who participated in Cohort S3, showing AUC and Cmax exposures at least 3-fold less than the cohort dose escalation criteria for exposure limit for AUD and Cmax. If AUC or Cmax are within 3-fold of the halting limit, then Cohort S5 may utilize the lower dose of 250mg evaluated in participants from Cohort S2, who were given a lower dose of 250mg in the fasted state, unless the PSRT decides a different cohort (Cohort S2) should return based on blinded Pharmacokinetics (PK) results. 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 secondary objective of part 1 is to characterize the PK profile of VNT-101 in plasma after single oral dose of VNT-101 in fasted healthy adult participants and one dose in fed healthy adult participants.
In Part 2, approximately 30 healthy adult participants in 3 cohorts (Cohorts M1 to M3) of 10 participants each (8 active and 2 placebo) are planned for sequential randomization and evaluation. Cohorts will be dosed sequentially in an ascending fashion. In each cohort, participants will receive under fasting conditions 11 oral doses of VNT-101 or placebo twice daily (BID) for 5 days with an additional dose being administered on the morning of Day 6. 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. The Secondary objectives are 1) To characterize the PK profile of VNT-101 in plasma after multiple oral doses of VNT-101 in healthy adult participants and 2) To characterize the PK profile of VNT-101 in urine after multiple oral doses of VNT-101 in healthy adult participants.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 75N93024F00001 | None | None | View |