NCT06937593

A Study to Evaluate Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Multiple Doses of VIS954

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Visterra, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	VIS954	A humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
DRUG	Placebo	VIS954 Placebo

Timeline

• Start date: 2025-03-13
• Primary completion: 2026-01-06
• Completion: 2026-02-13
• First posted: 2025-04-22
• Last updated: 2025-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study