A Phase1 Study of VIB9600

December 10, 2024 updated by: Amgen

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Trial & Consulting Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  1. Healthy male and female subjects aged 18 through 65 years at the time of consent.
  2. Body mass index (BMI) of 19.0 through 35.0 kg/m2 at screening and minimum weight of 50 kg.
  3. Females must have been surgically sterilized.
  4. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from Day 1 through to the final follow-up visit.
  5. Able and willing to comply with the requirements of the protocol.

Key Exclusion Criteria:

  1. Concurrent enrollment in another clinical study involving an investigational treatment.
  2. Received administration of an investigational drug or participated in a device trial within 3 months prior to screening (Visit 1).
  3. Subject is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned.
  4. History, or a reason to believe that a subject has a history, of drug or alcohol abuse within the 2 years prior to screening.
  5. Positive test for drugs of abuse.
  6. Donation of blood or blood products in excess of 500 mL within 3 months prior to screening. Not agreeing to refrain from blood or blood product donations during study participation.

  7. Receiving any of the prohibited concomitant medications:

    1. Any immunotherapy or immunosuppressive therapy
    2. Chronic use of steroid medications
    3. Immunoglobulin or blood products
    4. Live vaccines
    5. Anticoagulants
    6. Aspirin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VIB9600

Single dose of VIB9600 administered by IV infusion or SC injection.

Multiple dose VIB9600 administered by IV infusion every 2 weeks for 4 weeks.
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).
Placebo Comparator: Placebo
Placebo comparator administered by slow IV infusion or SC injection.
Drug: Placebos
Placebo administered by slow IV infusion or SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of single and multiple doses of VIB9600
Time Frame: 113 days
Treatment-emergent adverse events that occur on or after the day of IP administration.
113 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK of VIB9600 following single- and multiple- dose administration
Time Frame: SAD- Days 1, 2, 3, 5, 8, 16, 29, 43, 57, 85, 113; MAD- Days 1, 3, 8, 15, 22, 29, 32, 36, 43, 57, 86, 113
Concentration of VIB9600 in serum at different time points after IP administration.
SAD- Days 1, 2, 3, 5, 8, 16, 29, 43, 57, 85, 113; MAD- Days 1, 3, 8, 15, 22, 29, 32, 36, 43, 57, 86, 113
Immunogenicity of VIB9600 following single- and multiple-dose administration.
Time Frame: SAD- Days 1, 15, 29, 57, 85, 113; MAD- Days 1, 15, 29, 57, 85, 113
Immunogenicity as measured by the presence of anti-drug antibodies (ADA) to VIB9600
SAD- Days 1, 15, 29, 57, 85, 113; MAD- Days 1, 15, 29, 57, 85, 113

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

CTI Clinical Trial and Consulting Services

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2018

Primary Completion (Actual)

April 8, 2019

Study Completion (Actual)

April 8, 2019

Study Registration Dates

First Submitted

July 18, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • VIB9600.P1.S1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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