Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT06212804
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants
Sponsor:
Visterra, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Placebo-controlled, Double Blind, Single Ascending Dose, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Male and Female Participants
Status:
COMPLETED
Status Verified Date:
2025-06
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:
This is a first-in-human (FIH), randomized, placebo-controlled, double-blind, single ascending dose (SAD) study to assess the safety and tolerability of VIS954, a monoclonal antibody, in healthy adult male and female participants.
Detailed Description:
The study will be conducted in 6 sequential cohorts. Each cohort will enroll 9 participants, randomized to VIS954 or placebo at a ratio of 7:2.
On Day 1, a single dose of VIS954 or placebo will be administered SC. Sentinel participants will be utilized in each cohort. After 14 days, the safety data will be evaluated and a decision to admit and dose the next cohort will be made.
The total duration of the clinical study per participant will be up to 102 days (approximately 4 months).
On Day 1, a single dose of VIS954 or placebo will be administered SC. Sentinel participants will be utilized in each cohort. After 14 days, the safety data will be evaluated and a decision to admit and dose the next cohort will be made.
The total duration of the clinical study per participant will be up to 102 days (approximately 4 months).
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?: