NCT05847218

Phase 1 Clinical Trial of RHN-001 in Healthy Adult Volunteers

A Single-Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of RHN-001 in Healthy Adult Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: RH Nanopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 i.e., 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 i.e., 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 i.e. 0.0 hour (before dosing), 15.0 minutes, 30.0 minutes, 1.0 hour, 2.0, 3.0, 4.0, 8.0, 12.0 and 24.0 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.

Conditions

• Safety
• Tolerability
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	RHN-001 (one tablet 750mg)	Subjects in A1 and A2 will receive 750mg RHN-001 or matching placebo tablets in Fasted state and Fed states respectively with 240 mL ambient temperature water.
DRUG	RHN-001 (750mg * 2 Tablets)	Subjects in B1 and B2 will receive 1500mg RHN-001 (750mg tablet) or matching placebo tablets in Fasted state and Fed states respectively with 240 mL ambient temperature water.

Timeline

• Start date: 2023-03-09
• Primary completion: 2023-03-19
• Completion: 2023-03-19
• First posted: 2023-05-06
• Last updated: 2023-05-06

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study