NCT03621605

A Phase1 Study of VIB9600

A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of VIB9600 by Intravenous Infusion or Subcutaneous Injection in Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Overall design: Single-center, randomized, blinded, placebo-controlled single- and multiple-ascending dose study in healthy adult subjects.

Detailed description

This first-time-in-human (FTIH) SAD and MAD studies in healthy adult subjects will be conducted at one site in the United States of America (USA) on IV and SC VIB9600. Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.

Conditions

• Safety Issues

Interventions

Type	Name	Description
BIOLOGICAL	VIB9600	Part 1 (SAD): IV infusion (30, 100, 200, 300 or 1000 mg) or SC injection (300 mg) on Day 1. Part 2 (MAD): IV infusion (100 and 300 mg) every 2 weeks for 4 weeks (3 doses total; Days 1, 15 and 29).
DRUG	Placebos	Placebo administered by slow IV infusion or SC injection.

Timeline

• Start date: 2018-08-14
• Primary completion: 2019-04-08
• Completion: 2019-04-08
• First posted: 2018-08-08
• Last updated: 2024-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study