April 29, 2024 Source: drugdu 174
Recently, Chiatai Tianqing Pharmaceutical Group's self-developed Class 1 innovative drug TQA3038 (siRNA) successfully completed Phase I clinical study. The company will start the follow-up clinical study of TQA3038 injection in patients with chronic hepatitis B in the near future.
TQA3038 injection is a small interfering RNA (siRNA) drug independently developed by Chiatai Tianqing to target hepatitis B virus (HBV), with the indication of chronic hepatitis B. TQA3038, as an N-acetylgalactosamine (GalNAc)-conjugated siRNA drug, can be enriched in the liver, degrade the targeted RNA, inhibit translation of the relevant proteins, thus blocking the replication of hepatitis B virus. TQA3038 adopts a nucleic acid sequence with independent intellectual property rights and has strong in vitro and in vivo antiviral activity.
The "randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability and pharmacokinetic profile of TQA3038 in healthy adult subjects" initiated by the Company has been successfully completed recently. The study was the first human clinical trial of TQA3038, and all drug-related adverse events in the study were grade 1-2, with no serious adverse events occurring. The results of the study showed that TQA3038 was safe and well tolerated as expected, and its pharmacokinetic profile was consistent with its non-clinical pharmacokinetic profile, which is also in line with the pharmacokinetic profile of siRNA drugs.
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