Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05847218
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-03-22
Brief Title:
Phase 1 Clinical Trial of RHN-001 in Healthy Adult Volunteers
Sponsor:
RH Nanopharmaceuticals
Organization:
RH Nanopharmaceuticals
Study Overview
Official Title:
A Single-Dose Phase 1 Clinical Trial to Evaluate Safety Tolerability and Pharmacokinetics of RHN-001 in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical Trial is to assess the safety tolerability and Pharmacokinetic profile of 750 mg single oral dose of RHN-001 and 1500 mg of RHN-001 administered orally in fasted and fed conditions in healthy adult volunteers
Detailed Description:
The study is planned to be conducted in Two Phases Cohort A and Cohort B The first phase will be carried out in two Cohorts ie a single oral dose of investigational drug 750 mg or placebo under fasting Cohort A1 and a single oral dose of investigational drug 750 mg or placebo under fed conditions Cohort A2
The second phase of the study will also be carried out in two cohorts ie a single oral dose of 1500 mg or placebo under fasting Cohort B1 and a single oral dose of 1500 mg or placebo under fed conditions Cohort B2
Blood samples will be obtained from the volunteers at different time-points ie 00 hour before dosing 150 minutes 300 minutes 10 hour 20 30 40 80 120 and 240 hours post-dose in each cohort
Urine samples 10 mL for PK analysis will be collected after dosing for 24 hours whenever the subjects feel to urinate during their stay at the clinical trial site
The second phase of the study will also be carried out in two cohorts ie a single oral dose of 1500 mg or placebo under fasting Cohort B1 and a single oral dose of 1500 mg or placebo under fed conditions Cohort B2
Blood samples will be obtained from the volunteers at different time-points ie 00 hour before dosing 150 minutes 300 minutes 10 hour 20 30 40 80 120 and 240 hours post-dose in each cohort
Urine samples 10 mL for PK analysis will be collected after dosing for 24 hours whenever the subjects feel to urinate during their stay at the clinical trial site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None