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

NCT05418101 | Completed Phase 1 FDA Drug

• 2 other identifiers: VIS171-1012021-006246-12
• Study Type: interventional
• Target: 61
• Locations: 5 countries
• Sites: 10

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).

Conditions

Autoimmune Diseases

Keywords

Safety; Tolerability; Pharmacodynamics; Pharmacokinetics; Healthy participants

Outcome Measures

Primary Outcomes (1)

• Part A and Part B: Numbers of participants with treatment-emergent adverse events (TEAEs)

  Part A: From screening up to Day 29; Part B: From screening up to Day 71

Secondary Outcomes (8)

• 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

  Part A: From baseline up to Day 29; Part B: From baseline up to Day 71

• Part A and Part B: Mean change from baseline in percentage for Treg, helper T cells, cytotoxic T cells and natural killer cells

  Part A: From baseline up to Day 29; Part B: From baseline up to Day 71

• Part A and Part B: Maximum (peak) plasma VIS171 concentration (Cmax) over time

  Part A: From baseline up to Day 29; Part B: From baseline up to Day 71

• Part A and Part B: Time of maximum (peak) plasma VIS171 concentration (tmax)

  Part A: From baseline up to Day 29; Part B: From baseline up to Day 71

• Part A: Area under the concentration-time curve from time zero to the last observable concentration (AUClast) of VIS171

  Part A: From baseline up to Day 29

Study Arms (8)

Part A Cohort 1: Dose level 1

EXPERIMENTAL

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

Drug: VIS171; Drug: Placebo

Part A Cohort 2: Dose level 2

EXPERIMENTAL

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

Drug: VIS171; Drug: Placebo

Part A Cohort 3: Dose level 3

EXPERIMENTAL

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

Drug: VIS171; Drug: Placebo

Part A Cohort 4: Dose level 4

EXPERIMENTAL

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

Drug: VIS171; Drug: Placebo

Part A Cohort 5: Dose level 5

EXPERIMENTAL

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

Drug: VIS171; Drug: Placebo

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

EXPERIMENTAL

Participants will be randomized to MAD dose of VIS171.

Drug: VIS171

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

EXPERIMENTAL

Participants will be randomized to MAD dose of VIS171.

Drug: VIS171

Part B Cohort 3: Dose level and regimen to be determined from prior MAD and SAD Cohort(s)

EXPERIMENTAL

Participants will be randomized to MAD dose of VIS171.

Drug: VIS171

Interventions

VIS171 DRUG

Participants will receive VIS171 via SC route of administration.

Part A Cohort 1: Dose level 1; Part A Cohort 2: Dose level 2; Part A Cohort 3: Dose level 3; Part A Cohort 4: Dose level 4; Part A Cohort 5: Dose level 5; Part B Cohort 1: Dose level to be determined from SAD Cohort(s) data; Part B Cohort 2: Dose level to be determined from SAD Cohort(s) data; Part B Cohort 3: Dose level and regimen to be determined from prior MAD and SAD Cohort(s)

Placebo DRUG

Participants will receive Placebo via SC route of administration

Part A Cohort 1: Dose level 1; Part A Cohort 2: Dose level 2; Part A Cohort 3: Dose level 3; Part A Cohort 4: Dose level 4; Part A Cohort 5: Dose level 5

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \- 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (10)

UMHAT

Plovdiv, 4002, Bulgaria

Location

Ambulatory for Specialized Medical Help - skin and venereal diseases

Sofia, 1407, Bulgaria

Location

Comac Medical Ltd

Sofia, 1612, Bulgaria

Location

MBAL Sveta Sofia

Sofia, 1618, Bulgaria

Location

Diagnostic and Consultative Center Convex EOOD

Sofia, 1680, Bulgaria

Location

Universitaetsklinikum Bonn AöR

Bonn, 53127, Germany

Location

Universitätsmedizin der Johannes-Gutenberg-Universität Mainz

Rheinland-Pfalz, 55131, Germany

Location

Clinical republican Hospital

Chisinau, MD 2025, Moldova

Location

Radboud University Medical Center

Gelderland, 6525, Netherlands

Location

New Zealand Clinical Research

Christchurch, 8011, New Zealand

Location

Related Links

• Otsuka Clinical Trial Website
• Otsuka Clinical Trial Transparency

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Asher Schachter, MD

  Visterra, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Part A will be double masked; Part B is open label.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This phase 1 study has two parts. Part A is a randomized, double-blind, placebo controlled SAD assessment of SC VIS171 in healthy participants. Part B is an open-label, MAD basket assessment of SC VIS171 in participants with an autoimmune inflammatory disease

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 14, 2022
• Study Start: April 28, 2022
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); NL (1); BU (5); MO (1); NZ (1)