Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT06937593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Multiple Doses of VIS954
Sponsor:
Visterra, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Placebo-controlled, Double-blind, Multiple Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Participants
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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:
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of VIS954 compared with placebo in healthy adult participants.
Detailed Description:
The study will be conducted in 3 sequential cohorts. Each cohort will enroll 8 participants, randomized to VIS954 or placebo at a ratio of 6:2.
In each cohort, participants will be administered 6 doses of VIS954 or placebo with a dosing frequency of once every 2 weeks (Q2W). A Safety Monitoring Committee (SMC) will review the data and approve escalation to the next planned dose level.
The total duration of the clinical trial for each participant will be up to approximately 7 months, including the screening period.
In each cohort, participants will be administered 6 doses of VIS954 or placebo with a dosing frequency of once every 2 weeks (Q2W). A Safety Monitoring Committee (SMC) will review the data and approve escalation to the next planned dose level.
The total duration of the clinical trial for each participant will be up to approximately 7 months, including the screening period.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: