A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and with Autoimmune Disease)

NCT ID: NCT05418101

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2024-03-13

Brief Summary

This is a phase 1 study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and in participants with autoimmune disease(s).

Detailed Description

This is a multicenter, 2-part combined Single ascending dose (SAD) and Multiple ascending dose (MAD) First-in-Human (FIH) study to investigate the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (Part A - SAD) and in participants with autoimmune inflammatory disease(s) (Part B - MAD).

Part A: Part A is a randomized, double-blind, placebo controlled SAD assessment of SC VIS171 in healthy participants. Up to 5 cohorts are planned, each comprising 8 participants (6 VIS171 and 2 placebo).

Part B: Part B is an open-label, MAD basket assessment of SC VIS171 in participants with autoimmune inflammatory disease(s). Two to 3 cohorts are planned, each comprising 12 participants.

Conditions

Autoimmune Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A Cohort 1: Dose level 1

Participants will be randomized to SAD dose of VIS171 (or placebo).

Group Type: EXPERIMENTAL

VIS171

Intervention Type: DRUG

Participants will receive VIS171 via SC route of administration.

Placebo

Intervention Type: DRUG

Participants will receive Placebo via SC route of administration

Part A Cohort 2: Dose level 2

Participants will be randomized to SAD dose of VIS171 (or placebo).

Group Type: EXPERIMENTAL

VIS171

Intervention Type: DRUG

Participants will receive VIS171 via SC route of administration.

Placebo

Intervention Type: DRUG

Participants will receive Placebo via SC route of administration

Part A Cohort 3: Dose level 3

Participants will be randomized to SAD dose of VIS171 (or placebo).

Group Type: EXPERIMENTAL

VIS171

Intervention Type: DRUG

Participants will receive VIS171 via SC route of administration.

Placebo

Intervention Type: DRUG

Participants will receive Placebo via SC route of administration

Part A Cohort 4: Dose level 4

Participants will be randomized to SAD dose of VIS171 (or placebo).

Group Type: EXPERIMENTAL

VIS171

Intervention Type: DRUG

Participants will receive VIS171 via SC route of administration.

Placebo

Intervention Type: DRUG

Participants will receive Placebo via SC route of administration

Part A Cohort 5: Dose level 5

Participants will be randomized to SAD dose of VIS171 (or placebo).

Group Type: EXPERIMENTAL

VIS171

Intervention Type: DRUG

Participants will receive VIS171 via SC route of administration.

Placebo

Intervention Type: DRUG

Participants will receive Placebo via SC route of administration

Part B Cohort 1: Dose level to be determined from SAD Cohort(s) data

Participants will be randomized to MAD dose of VIS171.

Group Type: EXPERIMENTAL

VIS171

Intervention Type: DRUG

Participants will receive VIS171 via SC route of administration.

Part B Cohort 2: Dose level to be determined from SAD Cohort(s) data

Participants will be randomized to MAD dose of VIS171.

Group Type: EXPERIMENTAL

VIS171

Intervention Type: DRUG

Participants will receive VIS171 via SC route of administration.

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.

Group Type: EXPERIMENTAL

VIS171

Intervention Type: DRUG

Participants will receive VIS171 via SC route of administration.

Interventions

VIS171

Participants will receive VIS171 via SC route of administration.

Intervention Type: DRUG

Placebo

Participants will receive Placebo via SC route of administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).

• Diagnosis of a specified autoimmune disease based on standard criteria for the condition.
• Other criteria may apply depending on the autoimmune condition.

Exclusion Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Visterra, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asher Schachter, MD

Role: PRINCIPAL_INVESTIGATOR

Visterra, Inc.

Locations

UMHAT

Plovdiv, , Bulgaria

Ambulatory for Specialized Medical Help - skin and venereal diseases

Sofia, , Bulgaria

Comac Medical Ltd

Sofia, , Bulgaria

MBAL Sveta Sofia

Sofia, , Bulgaria

Diagnostic and Consultative Center Convex EOOD

Sofia, , Bulgaria

Universitaetsklinikum Bonn AöR

Bonn, , Germany

Universitätsmedizin der Johannes-Gutenberg-Universität Mainz

Rheinland-Pfalz, , Germany

Clinical republican Hospital

Chisinau, , Moldova

Radboud University Medical Center

Gelderland, , Netherlands

New Zealand Clinical Research

Christchurch, , New Zealand

Countries

Bulgaria; Germany; Moldova; Netherlands; New Zealand

Other Identifiers

VIS171-101

Identifier Type: -

Identifier Source: org_study_id

2021-006246-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id