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最高研发阶段批准上市 |
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首次获批日期1955-04-18 |
A Phase 1 Randomized Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers
This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows:
To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered.
To determine the recommended Phase 2a dose (RP2D).
Secondary objectives:
• To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.
100 项与 Pulmoquine Therapeutics, Inc 相关的临床结果
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100 项与 Pulmoquine Therapeutics, Inc 相关的转化医学