Trials / Completed
CompletedNCT05418101
A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease)
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VIS171 | Participants will receive VIS171 via SC route of administration. |
| DRUG | Placebo | Participants will receive Placebo via SC route of administration |
Timeline
- Start date
- 2022-04-28
- Primary completion
- 2024-03-13
- Completion
- 2024-03-13
- First posted
- 2022-06-14
- Last updated
- 2026-04-15
Locations
10 sites across 5 countries: Bulgaria, Germany, Moldova, Netherlands, New Zealand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05418101. Inclusion in this directory is not an endorsement.