A Study of Orally Administered ZM-H1505R to Evaluate Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Doses in Healthy Participants

NCT04220801 ↗

Phase 1 Completed 64 enrolled Shanghai Zhimeng Biopharma, Inc.

RandomizedSequentialQuadruple-blindOther

Summary

ZM-H1505R is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Chronic Hepatitis B. The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also test how the study drug is taken up and eliminated by the body. An additional part of the study is to look at how this could be changed by giving the study drug with food.

Timeline

Start: 2020-02-17
Primary completion: 2020-11-18
Completion: 2020-11-18

Publications

Jiang X, Hua B, Liu G, Xia T, Deng A, Lu H, Guo R, Wang Z, Liang B, Chen H, Jin Q, Zhang Z. Safety, Tolerability, and Pharmacokinetics of a Novel Human Hepatitis B Virus Capsid Assembly Modulator Canocapavir: A Randomized First-in-Human Study. Gastro Hep Adv. 2023 Jan 7;2(4):524-531. doi: 10.1016/j.gastha.2023.01.001. eCollection 2023.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Canocapavir	Small molecule	25 mg	Oral
Subject	Canocapavir	Small molecule	75 mg	Oral
Subject	Canocapavir	Small molecule	150 mg	Oral
Subject	Canocapavir	Small molecule	300 mg	Oral
Subject	Canocapavir	Small molecule	450 mg	Oral
Subject	Canocapavir	Small molecule	600 mg	Oral
Subject	Canocapavir	Small molecule	750 mg	Oral
Subject	Canocapavir	Small molecule	900 mg	Oral

Indications

No indication recorded.