SNPMiner Trials (Home Page)
Report for Mutation H1505R
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 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 Drug: ZM-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 ---
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 2Description: 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 2Description: 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 2Description: 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 2Description: 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