NCT06212804

A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VIS954 in Healthy Adult Participants

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Visterra, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	VIS954	A humanized IgG4 monoclonal antibody.
OTHER	Placebo	VIS954 Placebo

Timeline

• Start date: 2023-11-21
• Primary completion: 2024-07-19
• Completion: 2024-07-19
• First posted: 2024-01-19
• Last updated: 2025-07-14
• Results posted: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study