Safety IssuesPhase 1NCT03621605

A Phase1 Study of VIB9600

A Phase 1 study testing VIB9600 in people with Safety Issues, run by Amgen at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Safety Issues
What is being tested?: VIB9600
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 14 Aug 2018to 8 Apr 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

CTI Clinical Trial & Consulting Clinical Research Center
Cincinnati, Ohio, 45212

Other trials in United States

About this study

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

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

Read the 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
Being tested: VIB9600, Placebos

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VIB9600Biological
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).
PlacebosDrug
Placebo administered by slow IV infusion or SC injection.

Study groups in NCT03621605
Study group	Role	What they receive
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. Receives: Biological: VIB9600
Placebo	Placebo comparator	Placebo comparator administered by slow IV infusion or SC injection. Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

PK of VIB9600 following single- and multiple- dose administration
Concentration of VIB9600 in serum at different time points after IP administration.
Measured: 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.
Immunogenicity as measured by the presence of anti-drug antibodies (ADA) to VIB9600
Measured: SAD- Days 1, 15, 29, 57, 85, 113; MAD- Days 1, 15, 29, 57, 85, 113

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 20188 Apr 2019

First posted8 Aug 2018
Study start14 Aug 2018
Primary completion8 Apr 2019
Study completion8 Apr 2019

Why it stopped: Study terminated due to tolerability issues.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Safety IssuesStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Model description: 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).
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03621605
Sponsor's protocol ID: VIB9600.P1.S1
Status last verified: Dec 2024
First submitted: 18 Jul 2018
Last updated: 13 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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. No abstract available.
PubMed 23045170
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.
PubMed 26457917
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.
PubMed 22861361
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.
PubMed 28620373
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.
PubMed 25056155
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.
PubMed 7955533
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.
PubMed 18370923
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.
PubMed 18560159
Pagnoux C. Updates in ANCA-associated vasculitis. Eur J Rheumatol. 2016 Sep;3(3):122-133. doi: 10.5152/eurjrheum.2015.0043. Epub 2016 Jan 29.
PubMed 27733943
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.
PubMed 8027554
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.
PubMed 16461139

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03621605
Acronym / sponsor ID: VIB9600.P1.S1
Conditions: Safety Issues
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated due to tolerability issues.
Enrolment: 24 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Collaborators: CTI Clinical Trial and Consulting Services
Study start: 14 Aug 2018 (actual)
Primary completion: 8 Apr 2019 (actual)
Study completion: 8 Apr 2019 (actual)
First posted: 8 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: 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).

Arm	Type	Receives
VIB9600	Experimental	Biological: VIB9600Single dose of VIB9600 administered by IV infusion or SC injection. Multiple dose VIB9600 administered by IV infusion every 2 weeks for 4 weeks.
Placebo	Placebo comparator	Drug: PlacebosPlacebo comparator administered by slow IV infusion or SC injection.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VIB9600Part 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).	Biological	VIB9600
PlacebosPlacebo administered by slow IV infusion or SC injection.	Drug	Placebo

Primary outcome

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.

2 secondary outcomes

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
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

Results and safety

The study was stopped early (reason given: Study terminated due to tolerability issues.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
Background: PubMed 23045170Jennette 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. No abstract available.
Background: PubMed 26457917Kallenberg CG. Pathogenesis and treatment of ANCA-associated vasculitides. Clin Exp Rheumatol. 2015 Jul-Aug;33(4 Suppl 92):S11-4. Epub 2015 Oct 12.
Background: PubMed 22861361Kettritz 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.
Background: PubMed 28620373Ludwig 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.
Background: PubMed 25056155McKinney 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.
Background: PubMed 7955533Mulder 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.
Background: PubMed 18370923Nimmerjahn F, Ravetch JV. Anti-inflammatory actions of intravenous immunoglobulin. Annu Rev Immunol. 2008;26:513-33. doi: 10.1146/annurev.immunol.26.021607.090232.
Background: PubMed 18560159Oganesyan 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.
Background: PubMed 27733943Pagnoux C. Updates in ANCA-associated vasculitis. Eur J Rheumatol. 2016 Sep;3(3):122-133. doi: 10.5152/eurjrheum.2015.0043. Epub 2016 Jan 29.
Background: PubMed 8027554Porges 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.
Background: PubMed 16461139Sampson 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VIB9600 in people with Safety Issues, run by Amgen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to tolerability issues.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of single and multiple doses of VIB9600 (time frame: 113 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03621605, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.