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Report for Clinical Trial NCT04220801

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Dose (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZM-H1505R

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.

NCT04220801 Healthy Volunteers

1 Interventions

Name: ZM-H1505R

Description: Single oral doses of 300, 450, 600, 750, and 900 mg of ZM-H1505R or placebo and multiple oral doses of 450, 600, and 750 mg of ZM-H1505R or placebo will be administered in a fasted state, or in the case of Cohort 3 (Part 1), a second dose of 600 mg will be administered in the fed state. During each SAD and MAD dosing period, 2 subjects in each cohort will receive placebo instead of ZM-H1505R. The dose levels may be adjusted based on the safety and tolerability obtained from the previous cohort.
Type: Drug
Group Labels: 8

Cohort 1 of Part 1 (SAD) Cohort 1 of Part 2 (MAD) Cohort 2 of Part 1(SAD) Cohort 2 of Part 2 (MAD) Cohort 3 of Part 1(SAD) Cohort 3 of Part 2 (MAD) Cohort 4 of Part 1(SAD) Cohort 5 of Part 1(SAD)


Primary Outcomes

Description: Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively. Safety evaluations will be based on the incidence, intensity, and relatedness of AEs

Measure: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

Time: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2

Description: Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively. Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject PE findings

Measure: Number of Participants With Abnormal Physical Examinations

Time: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2

Description: Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively. Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject vital signs

Measure: Number of Participants With Abnormal Vital Signs

Time: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2

Description: Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively. Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject clinical laboratory results

Measure: Number of Participants With Clinically Significant Laboratory Findings

Time: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2

Description: Safety data from subjects in Part 1 and Part 2 treated with placebo will be pooled, respectively. Safety evaluations will be based on the incidence, intensity, and relatedness of AEs and changes in subject ECGs.

Measure: Number of Participants With Abnormal ECGs

Time: 22 days for Cohorts 1, 2, 4, and 5; 36 days for Cohort 3 in part 1 and Chorts in part 2

Purpose: Other

Allocation: Randomized

Sequential Assignment


There is one SNP

SNPs


1 H1505R

A Randomized, Double-blind, Placebo-controlled, Sequential Single and Multiple Ascending Dose (SAD/MAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZM-H1505R. --- H1505R ---

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

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



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