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On January 24, 2024, Incannex Healthcare Inc., a pharmaceutical company, announced the initiation of patient dosing in a Phase 2 clinical trial for its drug candidate IHL-675A, aimed at treating rheumatoid arthritis (RA). The trial will evaluate the safety and efficacy of IHL-675A, a proprietary combination of Hydroxychloroquine Sulphate (HCQ) and cannabidiol (CBD), both known for their anti-inflammatory properties. The double-blind study will enroll 128 participants across 10 Australian sites, with the primary endpoint being pain and function relative to baseline at 24 weeks. The trial includes daily patient-reported outcomes and a sub-study using MRI to examine joint inflammation and damage. The results are expected to contribute to future regulatory applications, including the FDA505(b)2 new drug application. Incannex Healthcare has a robust intellectual property position over IHL-675A, which is also being considered for other inflammatory conditions. The announcement follows the successful completion of a Phase 1 trial that demonstrated the tolerability and favorable pharmacokinetics of IHL-675A.
On January 24, 2024, Incannex Healthcare Inc., a pharmaceutical company, announced the initiation of patient dosing in a Phase 2 clinical trial for its drug candidate IHL-675A, aimed at treating rheumatoid arthritis (RA). The trial will evaluate the safety and efficacy of IHL-675A, a proprietary combination of Hydroxychloroquine Sulphate (HCQ) and cannabidiol (CBD), both known for their anti-inflammatory properties. The double-blind study will enroll 128 participants across 10 Australian sites, with the primary endpoint being pain and function relative to baseline at 24 weeks. The trial includes daily patient-reported outcomes and a sub-study using MRI to examine joint inflammation and damage. The results are expected to contribute to future regulatory applications, including the FDA505(b)2 new drug application. Incannex Healthcare has a robust intellectual property position over IHL-675A, which is also being considered for other inflammatory conditions. The announcement follows the successful completion of a Phase 1 trial that demonstrated the tolerability and favorable pharmacokinetics of IHL-675A.
2024 年 1 月 24 日，製藥公司Incannex Healthcare Inc. 宣佈其候選藥物 IHL-675A 的二期臨床試驗開始爲患者給藥，該試驗旨在治療類風溼關節炎 (RA)。該試驗將評估 IHL-675A 的安全性和有效性，這是硫酸羥氯喹和大麻二酚（CBD）的專有組合，兩者都以其抗炎特性而聞名。這項雙盲研究將招收來自澳大利亞10個地點的128名參與者，主要終點是相對於基線的疼痛和功能，爲24周。該試驗包括患者報告的每日療效，以及一項使用核磁共振成像檢查關節炎症和損傷的子研究。預計研究結果將爲未來的監管應用做出貢獻，包括 FDA505 (b) 2 新藥申請。與 IHL-675A 相比，Incannex Healthcare 擁有強大的知識產權地位，也在考慮將其用於其他炎症性疾病。該公告是在成功完成一期試驗之後發佈的，該試驗證明了 IHL-675A 的耐受性和良好的藥代動力學。
2024 年 1 月 24 日，製藥公司Incannex Healthcare Inc. 宣佈其候選藥物 IHL-675A 的二期臨床試驗開始爲患者給藥，該試驗旨在治療類風溼關節炎 (RA)。該試驗將評估 IHL-675A 的安全性和有效性，這是硫酸羥氯喹和大麻二酚（CBD）的專有組合，兩者都以其抗炎特性而聞名。這項雙盲研究將招收來自澳大利亞10個地點的128名參與者，主要終點是相對於基線的疼痛和功能，爲24周。該試驗包括患者報告的每日療效，以及一項使用核磁共振成像檢查關節炎症和損傷的子研究。預計研究結果將爲未來的監管應用做出貢獻，包括 FDA505 (b) 2 新藥申請。與 IHL-675A 相比，Incannex Healthcare 擁有強大的知識產權地位，也在考慮將其用於其他炎症性疾病。該公告是在成功完成一期試驗之後發佈的，該試驗證明了 IHL-675A 的耐受性和良好的藥代動力學。
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