A Phase Ib, Blinded, Randomized, Multicenter, Multiple-Ascending-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A Administered by Subcutaneous Injection in Patients With Non-Healing Neuropathic Diabetic Foot Ulcers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 32
- 主要终点
- Percentage of Participants with Adverse Events
研究概览
简要总结
This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not respond adequately to standard wound care. Participants across multiple sites will be assigned to one of five cohorts (Cohort A, B, C, D, and E) based on the eligibility criteria and randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12 weeks in addition to standard wound care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of Type 1 or Type 2 diabetes and confirmed peripheral neuropathy
- •Have adequate circulation to the foot
- •Have an ulcer area at screening up to 6 cm^2
- •Up to date on all age-appropriate cancer screenings per local standards
排除标准
- •Have current evidence of osteomyelitis, cellulitis, or evidence of systemic infection
- •Have gangrene present on any part of the affected foot
- •Known peripheral arterial disease requiring revascularization
- •Have a glycated hemoglobin A1C level of greater than (>) 15% assessed at screening
- •Are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents
- •Have active malignancy or any history of a malignancy
- •Use of oral antibiotics at the time of randomization for any reason in participants to be enrolled in Cohorts A, B, E, and any additional uninfected patient cohorts
研究组 & 干预措施
Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1
Participants with 0.8-6.0 centimeters square (cm^2) index ulcer area at screening and no infection in index ulcer will receive UTTR1147A SC at Dose Level 1 for 12 weeks (a total of 4 doses).
干预措施: UTTR1147A (Drug)
Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2
Participants with 0.8-6.0 cm^2 index ulcer area at screening and no infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses).
干预措施: UTTR1147A (Drug)
Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2
Participants with 0.8-6.0 cm^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses).
干预措施: UTTR1147A (Drug)
Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2
Participants with 1.5-6.0 cm^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses).
干预措施: UTTR1147A (Drug)
Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3
Participants with 0.8-6.0 cm^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 3 for 12 weeks (a total of 4 doses).
干预措施: UTTR1147A (Drug)
Placebo
Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses).
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events
时间窗: Baseline up to Day 141
次要结局
- Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12(Baseline, Weeks 6 and 12)
- Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies(Day 1, 22, 64, 85, 99, early termination visit (up to Day 141))
- Serum Concentration of UTTR1147A(Pre-dose (0 h) on Days 1, 22, 43, and 64, on Days 4, 8, 71, 85, and 99, early termination (up to Day 141))