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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05418101




Registration number
NCT05418101
Ethics application status
Date submitted
3/06/2022
Date registered
14/06/2022

Titles & IDs
Public title
A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease)
Scientific title
A Phase 1, First-in-human, 2-part Study (Part 1 is a Single Ascending Dose in Healthy Participants; Part 2 is a Multiple Ascending Dose Study in Participants With Autoimmune Disease) to Evaluate the Safety, PD and PK of VIS171
Secondary ID [1] 0 0
2021-006246-12
Secondary ID [2] 0 0
VIS171-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune Diseases 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VIS171
Treatment: Drugs - Placebo

Experimental: Part A Cohort 1: Dose level 1 - Participants will be randomized to SAD dose of VIS171 (or placebo).

Experimental: Part A Cohort 2: Dose level 2 - Participants will be randomized to SAD dose of VIS171 (or placebo).

Experimental: Part A Cohort 3: Dose level 3 - Participants will be randomized to SAD dose of VIS171 (or placebo).

Experimental: Part A Cohort 4: Dose level 4 - Participants will be randomized to SAD dose of VIS171 (or placebo).

Experimental: Part A Cohort 5: Dose level 5 - Participants will be randomized to SAD dose of VIS171 (or placebo).

Experimental: Part B Cohort 1: Dose level to be determined from SAD Cohort(s) data - Participants will be randomized to MAD dose of VIS171.

Experimental: Part B Cohort 2: Dose level to be determined from SAD Cohort(s) data - Participants will be randomized to MAD dose of VIS171.

Experimental: Part B Cohort 3: Dose level and regimen to be determined from prior MAD and SAD Cohort(s) - Participants will be randomized to MAD dose of VIS171.


Treatment: Drugs: VIS171
Participants will receive VIS171 via SC route of administration.

Treatment: Drugs: Placebo
Participants will receive Placebo via SC route of administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A and Part B: Numbers of participants with treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
Part A: From screening up to Day 29; Part B: From screening up to Day 71
Secondary outcome [1] 0 0
Part A and Part B: Mean change from baseline in absolute number (cells/µL) for Treg, helper T cells, cytotoxic T cells and natural killer cells
Timepoint [1] 0 0
Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Secondary outcome [2] 0 0
Part A and Part B: Mean change from baseline in percentage for Treg, helper T cells, cytotoxic T cells and natural killer cells
Timepoint [2] 0 0
Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Secondary outcome [3] 0 0
Part A and Part B: Maximum (peak) plasma VIS171 concentration (Cmax) over time
Timepoint [3] 0 0
Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Secondary outcome [4] 0 0
Part A and Part B: Time of maximum (peak) plasma VIS171 concentration (tmax)
Timepoint [4] 0 0
Part A: From baseline up to Day 29; Part B: From baseline up to Day 71
Secondary outcome [5] 0 0
Part A: Area under the concentration-time curve from time zero to the last observable concentration (AUClast) of VIS171
Timepoint [5] 0 0
Part A: From baseline up to Day 29
Secondary outcome [6] 0 0
Part A: Area under the concentration-time curve from time zero to infinity (AUC8) for VIS171 concentration
Timepoint [6] 0 0
Part A: From baseline up to Day 29
Secondary outcome [7] 0 0
Part B: Area under the concentration-time curve over the dosing interval at steady-state (AUCtau)
Timepoint [7] 0 0
Part B: From baseline up to Day 71
Secondary outcome [8] 0 0
Part A and Part B: Number of participants with Anti-drug antibodies (ADA) positive for VIS171
Timepoint [8] 0 0
Part A: Day 1, 15, and 29; Part B: Day 1, 15, 29, 43, and 71

Eligibility
Key inclusion criteria
Inclusion criteria for both Part A and Part B:

* Male or female participant between 18 and 55 years of age, inclusive, at the screening visit (Part A and Part B [participants with selected autoimmune diseases]) or between 18 and 75 years of age, inclusive, at the screening visit (Part B [participants with specific autoimmune disease]).
* Body mass index between 17 and 35 kg/m^2.
* Female participants will be nonpregnant, nonlactating, and either postmenopausal for at least 2 years or surgically sterile for at least 3 months.
* Male participants with female partners of childbearing potential must agree to use double barrier contraception or abstain from sex during the study and until 90 days following the last dose of study intervention.

Additional inclusion criterion for Part A:

- Healthy, as determined by prestudy medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations).

Additional inclusion criteria for Part B (participants with specific autoimmune disease[s]):

* Diagnosis of a specified autoimmune disease based on standard criteria for the condition.
* Other criteria may apply depending on the autoimmune condition.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for both Part A and Part B:

Prior and Concomitant Therapy

* Receipt of high dose corticosteroid therapy within 4 weeks prior to screening.
* Receipt of belimumab within 6 months prior to screening.
* History of treatment with rituximab or ocrelizumab (or other B cell-depleting agent) within 12 months prior to screening.
* History of cytotoxic medications within the preceding 12 months.
* Receipt of blood products within 6 months prior to screening.

Prior/Concurrent Clinical Study Experience:

* Receipt of any investigational product within 4 weeks or 5 half-lives of the respective product prior to signing of the ICF, whichever is greater.
* Currently participating in another clinical study of any investigational drug, device, or intervention.

Diagnostic Assessments

* Participants with uncontrolled hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg in any position) or symptomatic hypotension.
* Any chronic infectious disease.
* Participant with a positive urine drug or alcohol breath screen test result at screening.

Other Exclusions:

* Any participant who has a history of alcohol or drug/chemical abuse.
* Participant who has donated > 500 mL of blood within 60 days prior to the start of screening or any plasma within 7 days prior to baseline (Day -1).
* History of opportunistic infection requiring hospitalization or intravenous (IV) antimicrobial treatment within 1 year prior to randomization.
* History of major surgery within 12 weeks of screening or will require major surgery during the study.
* Clinically significant electrocardiographic abnormalities, at screening.
* A QT interval corrected for heart rate using Fridericia's correction (QTcF) > 450 msec for male participants or > 470 msec for female participants at screening.
* Participant has received an organ transplant.
* History of any significant cardiovascular disease or thrombotic episode.
* History of cancer, apart from: squamous or basal cell carcinoma of the skin that has been successfully treated; cervical cancer in situ that has been successfully treated.
* Coronavirus Disease 2019 (COVID-19): current symptoms of infection; diagnosis of COVID-19 in the 21 days prior to Screening; ongoing diagnosis of "Long-COVID" symptoms.
* Received a vaccination, other than COVID-19 vaccination, during the 30 days prior to administration of the first dose of study intervention. A COVID-19 vaccination cannot be received within 7 days prior to the first dose of study intervention and until 14 days after the last dose.

Additional exclusion criteria for Part A:

Medical Conditions

* Participant has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or malignancy.
* Participant has a history or presence of proteinuria, chronic kidney disease, disease requiring immunosuppressive therapy (including systemic steroids), or is considered to be immunosuppressed for any other reason.
* History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis.
* Known immunodeficiency disorder.
* History of chronic infection or any infection requiring hospitalization or treatment with antivirals, antibiotics, or antifungal therapy within 30 days prior to administration of the study intervention.
* Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 × the upper limit of normal (ULN).
* Total bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN is acceptable if total bilirubin is fractionated and direct bilirubin < 35%).
* Known hepatic or biliary abnormalities.

Additional exclusion criterion for Part A and Part B (participants with participants with specific autoimmune disease may apply depending upon the autoimmune condition).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/02/2024
Sample size
Target
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Plovdiv
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Sofia
Country [3] 0 0
Germany
State/province [3] 0 0
Bonn
Country [4] 0 0
Germany
State/province [4] 0 0
Rheinland-Pfalz
Country [5] 0 0
Moldova, Republic of
State/province [5] 0 0
Chisinau
Country [6] 0 0
Netherlands
State/province [6] 0 0
Gelderland
Country [7] 0 0
New Zealand
State/province [7] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Visterra, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Asher Schachter, MD
Address 0 0
Visterra, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05418101