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A Phase1 Study of VIB9600

NCT03621605 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-13

No results posted yet for this study

Summary

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

Conditions

  • Safety Issues

Interventions

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.

Sponsors & Collaborators

  • CTI Clinical Trial and Consulting Services

    collaborator OTHER

  • Amgen

    lead INDUSTRY

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-14
Primary Completion
2019-04-08
Completion
2019-04-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621605 on ClinicalTrials.gov