Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis

Study Director
Jeffrey Hafkin
Start Date
10 / 2018
Trial Phase
Phase I
Trial Status
in data analysis
Current Enrollment
122 Feb 2022
Target Enrollment

This is a multiple-dose trial of OPC-167832 with 2 stages.

Stage 1 is a multiple ascending dose trial planned to be conducted in 4 sequential cohorts of 18 participants each. There will be 2 arms (OPC-167832, RHEZ) in each cohort.

Stage 2 will be a parallel group comparison of 4 treatment regimens:

1) low dose OPC-167832 plus delamanid

2) high dose OPC-167832 plus delamanid

3) delamanid only

4) RHEZ.