A Phase IB, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Patients With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care Antibiotics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 16
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S when given in addition to anti-staphylococcal SOC antibiotics to participants with methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index greater than or equal (>/=) 18 to less than or equal to (</=) 40 kg/m^2
- •At randomization, participants must have >/=1 blood culture or molecular diagnostic that is positive for Staphylococcal aureus (S. aureus) collected in the previous 120 hours
- •In the investigator's judgment, an expected treatment duration for S. aureus intravenous infection with anti-staphylococcal SOC antibiotics >/= 4 weeks
排除标准
- •The presence of an intravascular catheter that is not planned to be removed within 96 hours of study randomization
- •S. aureus bacteremia associated with an intracardiac device and/or intravascular prosthetic material (including hemodialysis access graft)
- •In the investigator's judgement, S. aureus bacteremia involving infection of a prosthetic joint or vertebral hardware
- •In participants with cirrhosis, a Child-Pugh Score of Class B or C
- •Known rifampicin-resistant S. aureus
- •Anticipated receipt of a rifamycin class (excluding rifaxamin) antibiotic from Day 1 to study completion/discontinuation
- •In the investigator's judgment, the need for emergent valve surgery at the time of randomization or a high likelihood of cardiac surgery within 3 days after randomization
- •Polymicrobial bacteremia
- •Participants with significant immune suppression
- •Participants with evidence of liver disease
- •History or presence of an abnormal electrocardiogram (ECG)
- •Exposure to any biological therapy or investigational biological agent within 90 days prior to the screening evaluation or have received any other investigational treatment 30 days prior to the screening evaluation
研究组 & 干预措施
DSTA4637S low dose level + SOC
DSTA4637S low dose level intravenous (IV) infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
干预措施: DSTA4637S (Drug)
DSTA4637S low dose level + SOC
DSTA4637S low dose level intravenous (IV) infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
干预措施: SOC (Drug)
DSTA4637S intermediate dose level+ SOC
DSTA4637S intermediate dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
干预措施: DSTA4637S (Drug)
DSTA4637S intermediate dose level+ SOC
DSTA4637S intermediate dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
干预措施: SOC (Drug)
DSTA4637S high dose level+ SOC
DSTA4637S high dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
干预措施: DSTA4637S (Drug)
DSTA4637S high dose level+ SOC
DSTA4637S high dose level IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
干预措施: SOC (Drug)
Placebo + SOC
Placebo matched to DSTA4637S IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
干预措施: Placebo (Drug)
Placebo + SOC
Placebo matched to DSTA4637S IV infusion will be administered within 24 hours of randomization on Day 1 and then every 7 days up to 6 doses of study drug in addition to anti-staphylococcal SOC antibiotics.
干预措施: SOC (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Baseline up to approximately 156 Days
次要结局
- Measure of Unconjugated dmDNA31 measured by Plasma(Baseline up to approximately 156 Days)
- Measure of DSTA4637S Total Antibody measured by Serum(Baseline up to approximately 156 Days)
- Measure of Antibody-Conjugated 4-Dimethylamino Piperidino-Hydroxybenzoxazino Rifamycin (dmDNA31) measured by Plasma(Baseline up to approximately 156 Days)
- Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to DSTA4637S(Baseline up to approximately 156 Days)