NCT03173599

The Safety and Tolerability of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers

A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design Conducted in Chinese Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Guangzhou Yipinhong Pharmaceutical CO.,LTD · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted in Chinese Healthy Adult Volunteers.

Detailed description

A study to evaluate the safety and tolerability of ascending single oral doses of metacavir enteric-coated capsules using a placebo-controlled design conducted in Chinese healthy adult volunteers, and to provide references for the clinical trial of the next phase Ⅰ and Ⅱ. 48 eligible healthy subjects are involved. According to the set ascending-doses groups, subjects will be randomized in a 3:1 proportion to orally take a single dose of Metacavir enteric-coated capsule or placebo on the condition of fasting. Each group has 8 people, evenly composed of men and women. The beginning dose of the study is 40mg/d.According to the dose escalation method, subjects who have successfully completed tests of the previous dose group and passed the safety assessment will enter the next dose group with the same method. All subjects check in the phaseⅠresearch center one day early before taking the test drug. Vital signs and ECG will be observed before and 0.5,1,2,4,8,12,18,24,48,72 hours after administration and at the follow-up day which is the 7th day since administration. Laboratory tests will be conducted before and 6,24,48,72 hours after administration and at the follow-up day , and the adverse drug events are observed throughout the test.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	PNA 40mg	The beginning dose is 40mg.
DRUG	PNA 80mg	The single dose is 80mg.
DRUG	PNA 160mg	The single dose is 160mg.
DRUG	PNA 240mg	The single dose is 240mg.
DRUG	PNA 360mg	The single dose is 360mg.
DRUG	PNA 480mg	The single dose is 480mg.
DRUG	PNA Placebo	The beginning dose is 40mg/d, the dose escalation method is 40mg/80mg/160mg/240mg/360mg/480mg.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2017-06-02
• Last updated: 2017-06-02

Locations

1 site across 1 country: China