A Phase I Study of SHEN26 Capsule in Healthy Participants

Phase 1 Completed 86 enrolled Shenzhen Kexing Pharmaceutical Co., Ltd.

RandomizedSequentialQuadruple-blindTreatment

Summary

This is a randomized, double-blind, and placebo-controlled phase I clinical trial. It is designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of SHEN26 capsules after single and multiple ascending dosing in healthy Chinese adult participants, and the food effect on the PK profile of SHEN26 capsules.

Timeline

Start: 2022-08-08
Primary completion: 2022-12-11
Completion: 2022-12-11

Publications

Sun C, Liu H, Ouyang Z, Ding J, Zhang Q, Ma H, Xu D, Zhang Q, Zhou R, Yang M, Hu W. Safety, tolerability, and pharmacokinetics of the novel RdRp inhibitor SHEN26 against SARS-CoV-2: a randomized, placebo-controlled, double-blind Phase I study in healthy subjects. Expert Opin Investig Drugs. 2024 May;33(5):533-542. doi: 10.1080/13543784.2024.2347302. Epub 2024 Apr 30.
Zhou Q, Yang S, Cao L, Yang Y, Xu T, Chen Q, Lu H, Li Y, Guo D, Zhang X. Preclinical characterization and anti-SARS-CoV-2 efficacy of ATV014: an oral cyclohexanecarboxylate prodrug of 1'-CN-4-aza-7,9-dideazaadenosine C-nucleoside. Signal Transduct Target Ther. 2023 Jan 12;8(1):27. doi: 10.1038/s41392-023-01310-0. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SHEN26	Small molecule	50 mg	Oral
Subject	SHEN26	Small molecule	200 mg	Oral
Subject	SHEN26	Small molecule	400 mg	Oral
Subject	SHEN26	Small molecule	600 mg	Oral
Subject	SHEN26	Small molecule	800 mg	Oral
Subject	SHEN26	Small molecule	1200 mg	Oral

Indications

No indication recorded.