A Phase1 Study of VIB9600

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03621605
• Other study ID #: VIB9600.P1.S1
• Status: Terminated
• Phase: Phase 1
• Start date: August 14, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: April 2019
• Source: Viela Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety Issues

Intervention

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.

Locations

Country	Name	City	State
United States	CTI Clinical Trial & Consulting Clinical Research Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Viela Bio	CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

United States, 

References & Publications (11)

Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, Flores-Suarez LF, Gross WL, Guillevin L, Hagen EC, Hoffman GS, Jayne DR, Kallenberg CG, Lamprecht P, Langford CA, Luqmani RA, Mahr AD, Matteson EL, Merkel PA, Ozen S, Pusey CD, Rasmussen N, Rees AJ, Scott DG, Specks U, Stone JH, Takahashi K, Watts RA. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum. 2013 Jan;65(1):1-11. doi: 10.1002/art.37715. — View Citation

Kallenberg CG. Pathogenesis and treatment of ANCA-associated vasculitides. Clin Exp Rheumatol. 2015 Jul-Aug;33(4 Suppl 92):S11-4. Epub 2015 Oct 12. Review. — View Citation

Kettritz R. How anti-neutrophil cytoplasmic autoantibodies activate neutrophils. Clin Exp Immunol. 2012 Sep;169(3):220-8. doi: 10.1111/j.1365-2249.2012.04615.x. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Nimmerjahn F, Ravetch JV. Anti-inflammatory actions of intravenous immunoglobulin. Annu Rev Immunol. 2008;26:513-33. doi: 10.1146/annurev.immunol.26.021607.090232. Review. — View Citation

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. — View Citation

Pagnoux C. Updates in ANCA-associated vasculitis. Eur J Rheumatol. 2016 Sep;3(3):122-133. Epub 2016 Jan 29. Review. — View Citation

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. — View Citation

Sampson HA, Muñoz-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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PK of VIB9600 following single- and multiple- dose administration	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
Secondary	Immunogenicity of VIB9600 following single- and multiple-dose administration.	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