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
概览
- 阶段
- 1 期
- 干预措施
- Placebo
- 疾病 / 适应症
- Autoimmune Diseases
- 发起方
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- 入组人数
- 61
- 试验地点
- 19
- 主要终点
- Part A and Part B: Numbers of participants with treatment-emergent adverse events (TEAEs)
- 状态
- 已完成
- 最后更新
- 17天前
概览
简要总结
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).
详细描述
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.
研究者
入排标准
入选标准
- •Inclusion criteria for both Part A and Part B:
- •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\^
- •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).
- •Additional inclusion criteria for Part B (participants with specific autoimmune disease\[s\]):
- •Diagnosis of a specified autoimmune disease based on standard criteria for the condition.
- •Other criteria may apply depending on the autoimmune condition.
排除标准
- •Exclusion criteria for both Part A and Part B:
- •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.
研究组 & 干预措施
Part A Cohort 1: Dose level 1
Participants will be randomized to SAD dose of VIS171 (or placebo).
干预措施: Placebo
Part A Cohort 2: Dose level 2
Participants will be randomized to SAD dose of VIS171 (or placebo).
干预措施: Placebo
Part A Cohort 3: Dose level 3
Participants will be randomized to SAD dose of VIS171 (or placebo).
干预措施: Placebo
Part B Cohort 1: Dose level to be determined from SAD Cohort(s) data
Participants will be randomized to MAD dose of VIS171.
干预措施: VIS171
Part B Cohort 2: Dose level to be determined from SAD Cohort(s) data
Participants will be randomized to MAD dose of VIS171.
干预措施: VIS171
Part A Cohort 4: Dose level 4
Participants will be randomized to SAD dose of VIS171 (or placebo).
干预措施: Placebo
Part A Cohort 5: Dose level 5
Participants will be randomized to SAD dose of VIS171 (or placebo).
干预措施: Placebo
Part A Cohort 2: Dose level 2
Participants will be randomized to SAD dose of VIS171 (or placebo).
干预措施: VIS171
Part A Cohort 1: Dose level 1
Participants will be randomized to SAD dose of VIS171 (or placebo).
干预措施: VIS171
Part A Cohort 4: Dose level 4
Participants will be randomized to SAD dose of VIS171 (or placebo).
干预措施: VIS171
Part A Cohort 3: Dose level 3
Participants will be randomized to SAD dose of VIS171 (or placebo).
干预措施: VIS171
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.
干预措施: VIS171
Part A Cohort 5: Dose level 5
Participants will be randomized to SAD dose of VIS171 (or placebo).
干预措施: VIS171
结局指标
主要结局
Part A and Part B: Numbers of participants with treatment-emergent adverse events (TEAEs)
时间窗: Part A: From screening up to Day 29; Part B: From screening up to Day 71
次要结局
- 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: 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)
- 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)