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

NCT05847218 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-05-06

No results posted yet for this study

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.

Conditions

  • Safety
  • Tolerability
  • Pharmacokinetics

Interventions

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.

Sponsors & Collaborators

  • Center for Bioequivalence Studies and Clinical Research

    collaborator OTHER

  • RH Nanopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Muhammad Raza Shah, PhD · Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi, Pakistan

  • Izhar Hasan, MD, PhD · RH Nanopharmaceuticals LLC, Princeton, NJ 088540

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2023-03-19
Completion
2023-03-19
FDA Drug
Yes

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05847218 on ClinicalTrials.gov