A Randomized, Double-blind, Placebo-Controlled, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 in Subjects With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.
研究概览
简要总结
A Randomized, Placebo-Controlled, Double-blind, Dose Escalation Study to Assess Safety, Efficacy and Pharmacokinetics of GMA301 Injection in Subjects with Pulmonary Arterial Hypertension
详细描述
Drug: Q4W GMA301 IV injections (300 mg) Drug: Q4W GMA301 IV injections (600 mg) Drug: Q4W GMA301 IV injections (1000 mg) Drug: Q4W GMA301 IV injections (1800 mg) Other: Q4W placebo IV injections
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Q4W GMA301 IV injections (600 mg)
Drug: Q4W GMA301 IV injections (600 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
干预措施: Q4W placebo IV injections (Other)
Q4W GMA301 IV injections (300 mg)
Drug: Q4W GMA301 IV injections (300 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
干预措施: Q4W GMA301 IV injections (300 mg) (Drug)
Q4W GMA301 IV injections (300 mg)
Drug: Q4W GMA301 IV injections (300 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
干预措施: Q4W placebo IV injections (Other)
Q4W GMA301 IV injections (600 mg)
Drug: Q4W GMA301 IV injections (600 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
干预措施: Q4W GMA301 IV injections (600 mg) (Drug)
Q4W GMA301 IV injections (1000 mg)
Drug: Q4W GMA301 IV injections (1000 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
干预措施: Q4W GMA301 IV injections (1000 mg) (Drug)
Q4W GMA301 IV injections (1000 mg)
Drug: Q4W GMA301 IV injections (1000 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
干预措施: Q4W placebo IV injections (Other)
Q4W GMA301 IV injections (1800 mg)
Drug: Q4W GMA301 IV injections (1800 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
干预措施: Q4W GMA301 IV injections (1800 mg) (Drug)
Q4W GMA301 IV injections (1800 mg)
Drug: Q4W GMA301 IV injections (1800 mg) Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
Other: Q4W placebo IV injections Placebo is indistinguishable from GMA301
干预措施: Q4W placebo IV injections (Other)
结局指标
主要结局
The incidence of Treatment-emergent Adverse Events (TEAE) in subjects assigned to GMA301 compared with those assigned to placebo.
时间窗: Through study completion (up to 22 weeks)
次要结局
- Pharmacokinetics (Area under the serum concentration- time curve from time zero to the last measurable concentration)(Through study completion (up to 22 weeks))
- Comparison of GMA301 treatment effect at Week 12 versus baseline regarding the pulmonary vascular resistance (PVR) based on right heart catheterization (RHC)(Baseline to Week 12)
- Comparing 6MWT distance(Baseline to Week 12)