A Phase1 Study of VIB9600

NCT03621605 | Terminated Phase 1 FDA Drug

• 1 other identifier: VIB9600.P1.S1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of single and multiple doses of VIB9600

  Treatment-emergent adverse events that occur on or after the day of IP administration.

  113 days

Secondary Outcomes (2)

• PK of VIB9600 following single- and multiple- dose 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.

  SAD- Days 1, 15, 29, 57, 85, 113; MAD- Days 1, 15, 29, 57, 85, 113

Study Arms (2)

VIB9600

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo comparator administered by slow IV infusion or SC injection.

Drug: Placebos

Interventions

VIB9600 BIOLOGICAL

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).

VIB9600

Placebos DRUG

Placebo administered by slow IV infusion or SC injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female subjects aged 18 through 65 years at the time of consent.
• Body mass index (BMI) of 19.0 through 35.0 kg/m2 at screening and minimum weight of 50 kg.
• Females must have been surgically sterilized.
• 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.
• Able and willing to comply with the requirements of the protocol.

You may not qualify if:

• Concurrent enrollment in another clinical study involving an investigational treatment.
• Received administration of an investigational drug or participated in a device trial within 3 months prior to screening (Visit 1).
• Subject is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned.
• History, or a reason to believe that a subject has a history, of drug or alcohol abuse within the 2 years prior to screening.
• Positive test for drugs of abuse.
• 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.
• Receiving any of the prohibited concomitant medications:
• Any immunotherapy or immunosuppressive therapy
• Chronic use of steroid medications
• Immunoglobulin or blood products
• Live vaccines
• Anticoagulants
• Aspirin

Sponsors & Collaborators

• Amgen: lead
• CTI Clinical Trial and Consulting Services: collaborator

Study Sites (1)

CTI Clinical Trial & Consulting Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Related Publications (11)

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• Ludwig RJ, Vanhoorelbeke K, Leypoldt F, Kaya Z, Bieber K, McLachlan SM, Komorowski L, Luo J, Cabral-Marques O, Hammers CM, Lindstrom JM, Lamprecht P, Fischer A, Riemekasten G, Tersteeg C, Sondermann P, Rapoport B, Wandinger KP, Probst C, El Beidaq A, Schmidt E, Verkman A, Manz RA, Nimmerjahn F. Mechanisms of Autoantibody-Induced Pathology. Front Immunol. 2017 May 31;8:603. doi: 10.3389/fimmu.2017.00603. eCollection 2017.

  PMID: 28620373 BACKGROUND

• McKinney EF, Willcocks LC, Broecker V, Smith KG. The immunopathology of ANCA-associated vasculitis. Semin Immunopathol. 2014 Jul;36(4):461-78. doi: 10.1007/s00281-014-0436-6. Epub 2014 Jul 24.

  PMID: 25056155 BACKGROUND

• Mulder AH, Heeringa P, Brouwer E, Limburg PC, Kallenberg CG. Activation of granulocytes by anti-neutrophil cytoplasmic antibodies (ANCA): a Fc gamma RII-dependent process. Clin Exp Immunol. 1994 Nov;98(2):270-8. doi: 10.1111/j.1365-2249.1994.tb06137.x.

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• Oganesyan V, Gao C, Shirinian L, Wu H, Dall'Acqua WF. Structural characterization of a human Fc fragment engineered for lack of effector functions. Acta Crystallogr D Biol Crystallogr. 2008 Jun;64(Pt 6):700-4. doi: 10.1107/S0907444908007877. Epub 2008 May 14.

  PMID: 18560159 BACKGROUND

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  PMID: 27733943 BACKGROUND

• Porges AJ, Redecha PB, Kimberly WT, Csernok E, Gross WL, Kimberly RP. Anti-neutrophil cytoplasmic antibodies engage and activate human neutrophils via Fc gamma RIIa. J Immunol. 1994 Aug 1;153(3):1271-80.

  PMID: 8027554 BACKGROUND

• Sampson HA, Munoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, Brown SG, Camargo CA Jr, Cydulka R, Galli SJ, Gidudu J, Gruchalla RS, Harlor AD Jr, Hepner DL, Lewis LM, Lieberman PL, Metcalfe DD, O'Connor R, Muraro A, Rudman A, Schmitt C, Scherrer D, Simons FE, Thomas S, Wood JP, Decker WW. Second symposium on the definition and management of anaphylaxis: summary report--Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006 Feb;117(2):391-7. doi: 10.1016/j.jaci.2005.12.1303.

  PMID: 16461139 BACKGROUND

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Investigator and subject are blinded, sponsor and site pharmacist are unblinded.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A minimum of 56 subjects will be enrolled in 7 planned SAD cohorts (8 subjects per cohort). Subjects enrolled in SAD cohorts will be admitted to a Phase 1 unit and randomized to receive a single dose of VIB9600 or placebo administered by slow IV infusion or SC injection. A minimum of 16 subjects will be enrolled in 2 planned MAD cohorts (8 subjects per cohort). Subjects enrolled in the MAD cohorts will receive VIB9600 or placebo Q2W for 4 weeks (3 doses in total: one each on Days 1, 15 and 29).

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 8, 2018
• Study Start: August 14, 2018
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)