Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001352998
Ethics application status
Approved
Date submitted
12/11/2020
Date registered
15/12/2020
Date last updated
21/01/2022
Date data sharing statement initially provided
15/12/2020
Date results information initially provided
21/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
VIS649-102: A study assessing single doses of VIS649, in healthy adults.
Scientific title
VIS649-102: A sequential treatment, phase 1, open-label study to assess the pharmacokinetics, safety and tolerability, and pharmacodynamics of VIS649 solution administered subcutaneously in healthy male and female participants aged 18 to 55 years.
Secondary ID [1] 302507 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunoglobulin A Nephropathy 319371 0
Condition category
Condition code
Renal and Urogenital 317342 317342 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a single dose of VIS649 administered via subcutaneous injection by the investigator. Group 1 will receive 200 mg VIS649, Group 2 will receive 400 mg VIS649, Group 3 will receive 400 mg VIS649 and Group 4 will receive 600 mg VIS649.
Intervention code [1] 318799 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325376 0
Pharmacokinetic (PK) profile of a single subcutaneous (SC) dose of VIS649 including Cmax, AUC0-inf, and AUC0-last as determined through measurement of circulating serum VIS649 levels.
Timepoint [1] 325376 0
PK samples will be collected at 4 and 8 hours after receiving a single dose and then on days 2, 3, 5, 7, 9, 14, 28, 42, 56, 70, 84, 112 (End of study visit) post-dose.
Primary outcome [2] 325377 0
Characterize the safety and tolerability of VIS649 administered as a single SC dose as assessed by physical examination; recording vital signs (blood pressure, pulse, respiratory rate and oral temperature); clinical laboratory tests (serum chemistry, hematology and urinalysis); assessment of injection site pain from the Visual Analog Scale; and adverse events self-reported by the participant.
Timepoint [2] 325377 0
16 weeks post VIS649 administration
Secondary outcome [1] 387713 0
Pharmacokinetic (PK) profile of a single subcutaneous (SC) dose of VIS649 as determined through measurement of circulating serum VIS649 levels. The parameters measured will be:
Clast (time of last serum concentration),
tmax (time of maximum serum concentration),
tlast (time of last quantifiable observed concentration)
t1/2 (apparent terminal elimination half-life),
AUC0-28d (area under the concentration-time curve from day 0 to day 28),
AUC0-112d (area under the concentration-time curve from day 0 to day 112),
%AUCex (Percentage of AUC0-inf obtained by extrapolation);
Vd/F (apparent volume of distribution),
CL/F (apparent clearance).
Timepoint [1] 387713 0
PK samples will be collected at 4 and 8 hours after receiving a single dose and then on days 2, 3, 5, 7, 9, 14, 28, 42, 56, 70, 84, 112 (End of study visit) post-dose.

Eligibility
Key inclusion criteria
Healthy males and females between 18 and 55 years of age (inclusive)
Body mass index (BMI) 17 - 32 kg/m2, inclusive
Willing to adhere to study rules and restrictions
Willing to follow contraception requirements
Capable of giving informed consent
Pass all screening assessments (WBC and platelets count; hemoglobin; eGFR; serum creatinine; glucose; serum IgG, IgM and IgA levels;
Willing and able to comply with study restrictions and to remain at the study site for the in-patient duration of the study and return for all follow-up visits
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Female participants who are pregnant or breastfeeding.
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 or is considered to be immunosuppressed for any reason.
History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis.
Known hypoglobulinemia disorder.
History of chronic infection or any infection requiring hospitalization or treatment within 30 days.
Received vaccination in prior 30 days
Alanine transaminase (ALT) or aspartate transaminase (AST) >1.5 x ULN; total bilirubin .1.5 x ULN.
Known hepatic or biliary abnormalities
A QT interval corrected for heart rate using Fridericia's correction (QTcF) .450 msec for males or >470 msec for females.
Previous receipt of antibody or biologic therapy
Concomitant use of marketed or investigational systemic immunosuppressive or immunomodulatory medications is prohibited and requires a a washout period prior to screening.
Is participating in another clinical study of any investigational drug, device or intervention within the last 30 days or 5 half-lives of the intervention, whichever is longer.
Meets required diagnostic assessments for blood pressure, presence of hepatitis B surface antigen, chronic hepatitis C infection, presence of hepatitis B core antibody, known history of positive human immunodeficiency virus, positive urine drug or alcohol breath screen at screening or Day -1.
Male who consumes more than 15 standard alcohol drinks per week or female who consumes more than 10 standard alcohol drinks per week.
Participant who has donated >500 ml of blood within 7 days prior to baseline.
Is an employee of the clinical research team.
Participant judged by the primary investigator or the medical monitor to be inappropriate for the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/12/2020
Date of last participant enrolment
Anticipated
15/02/2021
Actual
6/04/2021
Date of last data collection
Anticipated
15/06/2021
Actual
26/07/2021
Sample size
Target
48
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 23052 0
New Zealand
State/province [1] 23052 0

Funding & Sponsors
Funding source category [1] 306939 0
Commercial sector/Industry
Name [1] 306939 0
Visterra, Inc.
Country [1] 306939 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
IQVIA RDS Pty Limited
Address
Level 8
201 Pacific Highway
St. Leonards
Sydney
NSW 2065
Country
Australia
Secondary sponsor category [1] 307499 0
None
Name [1] 307499 0
Address [1] 307499 0
Country [1] 307499 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307082 0
Health and Disability Ethics Committee
Ethics committee address [1] 307082 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 307082 0
New Zealand
Date submitted for ethics approval [1] 307082 0
12/10/2020
Approval date [1] 307082 0
02/11/2020
Ethics approval number [1] 307082 0

Summary
Brief summary
This is a Phase 1, Open-label study performed to determine the pharmacokinetics (PK), safety and tolerability and pharmacodynamics (PD) of the study drug, VIS649 solution when administered subcutaneously in healthy non-Japanese and Japanese males and females aged between 18 and 55 years. The assessment will be done in up to 3 dose cohorts. The results will facilitate the treatment of immunoglobulin (Ig) A nephropathy. The study comprises of a screening period up to 30 days before dosing, an in-house stay for approximately 3 days (in which dosing will be done on first day and discharge on second day), followed by a post-administration period of 16 weeks with follow-up visits. The total duration of the clinical study per participant will be up to approximately 20 weeks (5 months), including the screening period. A total of 36 participants (12 in each cohort) will be enrolled with 9 Non-Japanese and 3 Japanese in each cohort. A Safety Monitoring Committee will be used for reviewing safety and tolerability data of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105970 0
Dr Paul Hamilton
Address 105970 0
Auckland Clinical Studies Ltd.
ACS House
3 Ferncroft Street
Auckland, New Zealand
1010
Country 105970 0
New Zealand
Phone 105970 0
+64 9 373 3474
Fax 105970 0
Email 105970 0
[email protected]
Contact person for public queries
Name 105971 0
Vijaykumar Rajendrakumar Prajapati
Address 105971 0
IQVIA RDS Pty Ltd.
Level 8, 201 Pacific Highway
St. Leonards, Sydney, NSW 2065
Country 105971 0
Australia
Phone 105971 0
+61 2 9016 8100
Fax 105971 0
Email 105971 0
[email protected]
Contact person for scientific queries
Name 105972 0
Asher Schachter
Address 105972 0
Visterra, Inc.
275 2nd Avenue
Waltham, MA 02451
Country 105972 0
United States of America
Phone 105972 0
+1 617 417 9792
Fax 105972 0
Email 105972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
With a single site and limited participants data sharing is not recommended for reasons of patient confidentiality. Also as a small PK study for a specific drug applicability of data is limited.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSafety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Sibeprenlimab in Healthy Participants.2023https://dx.doi.org/10.1002/cpdd.1316
N.B. These documents automatically identified may not have been verified by the study sponsor.