Completed PHASE1 INTERVENTIONAL 7-arm NCT03036163

Phase 1 Study of PBTZ169

Open-label Prospective Noncomparative Study of Safety, Tolerability and Pharmacokinetics of PBTZ169 After Single and Multiple Fasting Oral Administration in Increasing Doses in Healthy Volunteers

Sponsor: Nearmedic Plus LLC

Conditions Tuberculosis

Interventions PBTZ169 - 160 mg PBTZ169 - 320 mg PBTZ169 - 320 mg (multiple administration) PBTZ169 - 40 mg PBTZ169 - 640 mg PBTZ169 - 640 mg (multiple administration) PBTZ169 - 80 mg

Updated 8 times since 2017 Last updated: Mar 26, 2020 Started: Jan 31, 2016 Primary completion: Sep 30, 2016 Completion: Nov 30, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Tuberculosis, this trial is completed. The trial is conducted by Nearmedic Plus LLC and has accumulated 8 data snapshots since 2016. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2023 — Jul 2024 [monthly]

Completed PHASE1
Dec 2022 — Jan 2023 [monthly]

Completed PHASE1
Jan 2021 — Dec 2022 [monthly]

Completed PHASE1

▶ Show 3 earlier versions

May 2020 — Jan 2021 [monthly]

Completed PHASE1
Jun 2018 — May 2020 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Jan 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Nearmedic Plus LLC
OCT LLC

Data source: Nearmedic Plus LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.