Pharmacokinetics of PN-232 in Healthy Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04819620|
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : July 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Drug: PN-232 Drug: Placebo||Phase 1|
Part 1: Approximately 32 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo as single doses.
Part 2: Up to 40 subjects will be enrolled into 4 cohorts to receive PN-232 or placebo once daily for 10 days.
Part 3: Twelve subjects will receive single doses of PN-232 in a 3-way, randomized, crossover fashion.
In total, approximately 84 subjects will participate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Double-Blind, Placebo-controlled Study of Single and Multiple Ascending Doses of PN-232 in Healthy Volunteers|
|Actual Study Start Date :||May 13, 2021|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: Single Dose
Single dose administration
Experimental: Multiple Dose
Multiple dose administration
Experimental: Solid Dose Comparison
Solid dose administration
- Safety of PN-232 [ Time Frame: 10 days ]Number and Severity of Adverse Events
- Peak concentration of PN-232 in plasma [ Time Frame: 10 days ]Peak concentration (Cmax) of PN-232
- Area under the Concentration (AUC) of PN-232 [ Time Frame: 10 days ]AUC over 24 hours on Day 10 for PN-232
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819620
|Contact: Study Directoremail@example.com|
|Australia, South Australia|
|Protagonist Clinical Site||Recruiting|
|Adelaide, South Australia, Australia, 5000|
|Australia, Western Australia|
|Protagonist Study Site||Recruiting|
|Nedlands, Western Australia, Australia, 6009|