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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006246-12 | EudraCT Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Cohort 1: Dose level 1 | Experimental | Participants will be randomized to SAD dose of VIS171 (or placebo). |
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| Part A Cohort 2: Dose level 2 | Experimental | Participants will be randomized to SAD dose of VIS171 (or placebo). |
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| Part A Cohort 3: Dose level 3 | Experimental | Participants will be randomized to SAD dose of VIS171 (or placebo). |
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| Part A Cohort 4: Dose level 4 | Experimental | Participants will be randomized to SAD dose of VIS171 (or placebo). |
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| Part A Cohort 5: Dose level 5 | Experimental | Participants will be randomized to SAD dose of VIS171 (or placebo). |
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| Part B Cohort 1: Dose level to be determined from SAD Cohort(s) data |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIS171 | Drug | Participants will receive VIS171 via SC route of administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Inclusion criteria for both Part A and Part B:
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]):
Exclusion Criteria:
Exclusion criteria for both Part A and Part B:
Prior and Concomitant Therapy
Prior/Concurrent Clinical Study Experience:
Diagnostic Assessments
Other Exclusions:
Additional exclusion criteria for Part A:
Medical Conditions
Additional exclusion criterion for Part A and Part B (participants with participants with specific autoimmune disease may apply depending upon the autoimmune condition).
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| Name | Affiliation | Role |
|---|---|---|
| Asher Schachter, MD | Visterra, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMHAT | Plovdiv | 4002 | Bulgaria | |||
| Ambulatory for Specialized Medical Help - skin and venereal diseases |
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| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
| Otsuka Clinical Trial Transparency | View source |
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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
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Part A will be double masked; Part B is open label.
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| Experimental |
Participants will be randomized to MAD dose of VIS171. |
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| Part B Cohort 2: Dose level to be determined from SAD Cohort(s) data | Experimental | Participants will be randomized to MAD dose of VIS171. |
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| 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. |
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| Placebo | Drug | Participants will receive Placebo via SC route of administration |
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| 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 |
| Part A: Area under the concentration-time curve from time zero to infinity (AUC∞) for VIS171 concentration | Part A: From baseline up to Day 29 |
| Part B: Area under the concentration-time curve over the dosing interval at steady-state (AUCtau) | Part B: From baseline up to Day 71 |
| Part A and Part B: Number of participants with Anti-drug antibodies (ADA) positive for VIS171 | Part A: Day 1, 15, and 29; Part B: Day 1, 15, 29, 43, and 71 |
| Sofia |
| 1407 |
| Bulgaria |
| Comac Medical Ltd | Sofia | 1612 | Bulgaria |
| MBAL Sveta Sofia | Sofia | 1618 | Bulgaria |
| Diagnostic and Consultative Center Convex EOOD | Sofia | 1680 | Bulgaria |
| Universitaetsklinikum Bonn AöR | Bonn | 53127 | Germany |
| Universitätsmedizin der Johannes-Gutenberg-Universität Mainz | Rheinland-Pfalz | 55131 | Germany |
| Clinical republican Hospital | Chisinau | MD 2025 | Moldova |
| Radboud University Medical Center | Gelderland | 6525 | Netherlands |
| New Zealand Clinical Research | Christchurch | 8011 | New Zealand |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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