CompletedNCT05847218Updated May 6, 2023

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

A Phase 1 interventional study of RHN-001 (one tablet 750mg) and RHN-001 (750mg * 2 Tablets) in Safety, Tolerability and Pharmacokinetics, sponsored by RH Nanopharmaceuticals. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by RH Nanopharmaceuticals · Phase 1, Interventional, and Other

From the registry’s dates

Primary completion was Mar 2023, 3 years 6 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

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.

Read the 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 studied

Safety
Tolerability
Pharmacokinetics

Keywords

Phase 1 study
Anti inflammatory
healthy volunteers

In context

Lead sponsor

This is the only study on the registry with RH Nanopharmaceuticals as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subject's written informed consent obtained prior to any study-related procedures.
Subject is a male/female with an age between 18 and 55 years of age, inclusive.
Subject has a body mass index between 18 and 32 kg/m2, inclusive.
Subject is judged to be in good health on the basis of medical history, complete physical examination, 12-lead electrocardiogram (ECG) and standard laboratory tests including complete hematology, blood chemistry, Lipid profile, Thyroid profile and urinalysis.
Subject understands the procedures and agrees to participate in the study program.

Exclusion criteria

Exclusion Criteria:

Subject is under the age of legal consent, or is mentally or legally incapacitated.
Subject has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering RHN-001 to the subject.
Subject has a recent history (10 years) of major cardiovascular, hepatic or renal disease.
Subject has liver function tests abnormalities with elevated AST or ALT greater than or equal to 2 times upper limit of normal and/or elevated bilirubin greater than or equal to 2 times upper limit of normal.
Subject has renal function tests abnormalities with serum creatinine greater than 1.8 g/dL.
Subject has any clinically significant abnormal hematological values in the opinion of the principal investigator.
Subject has abnormal serum concentrations of TSH, T3 or T4.
Subject has clinically significant abnormalities at physical examination, ECG or laboratory tests carried out at screening.
Subject has a history of psychiatric disorders, significant allergic conditions or known hypersensitivity to medications.
Subject is positive on testing for hepatitis B surface antigen, hepatitis C antibody or HIV 1 or 2 antibodies or tested positive for COVID-19 on rapid antigen testing.
Subject has donated blood within the 2 months before study drug administration.
Subject has a history of alcohol or drug abuse within the past year.
Subject used any over-the-counter drug during the 2 weeks prior to study drug administration (except occasional acetaminophen or vitamins).
Subject is positive on urine drug screening for drugs of abuse (cannabinoids, cocaine, opiates, amphetamines, barbiturates, benzodiazepines).
Subject tests positive for alcohol on Breath alcohol or urine screening.
Subject smokes more than 5 cigarettes per day.
Subject consumes caffeine more than 500 mg per day.
Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 64 participants (actual)

Study arms

Experimental
Cohort A1 (750mg RHN-001 or Placebo) in fasting state
Eligible 16 subjects will be randomized in Cohort A1 (n=16; 12 active: 4 Placebo) and fast for at least 10 hours on check-in day after dinner till 4 hours after they receive the investigational product (RHN-001 750mg caplet) or placebo at the study site on the morning of Day 2 of the study.
Drug: RHN-001 (one tablet 750mg)
Experimental
Cohort A2 (750mg RHN-001 or Placebo) in fed state
Eligible 16 subjects will be randomized in Cohort A2 (n=16; 12 active: 4 Placebo) and will receive the investigational product (RHN-001) or placebo on Day 2 (dosing day) within 30 minutes after a standard breakfast. All subjects will undergo a 24-hour PK study during their stay at the clinical trial site.
Drug: RHN-001 (one tablet 750mg)
Experimental
Cohort B1 (1500mg RHN-001 or Placebo) in fasting state
Eligible 16 subjects will be randomized in Cohort B1 (n=16; 12 active: 4 Placebo) and fast for at least 10 hours on check-in day after dinner till 4 hours after they receive the investigational product (RHN-001 1500mg caplet) or placebo at the study site on the morning of Day 2 of the study.
Drug: RHN-001 (750mg * 2 Tablets)
Experimental
Cohort B2 (1500mg RHN-001 or Placebo) in fed state
Eligible 16 subjects will be randomized in Cohort B2 (n=16; 12 active: 4 Placebo) and will receive the investigational product (RHN-001) or placebo on Day 2 (dosing day) within 30 minutes after a standard breakfast. All subjects will undergo a 24-hour PK study during their stay at the clinical trial site.
Drug: RHN-001 (750mg * 2 Tablets)

Interventions

DrugRHN-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.
DrugRHN-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.

What researchers measure

Primary outcomes

Safety and tolerability profile of SAD of RHN-001
Number of subjects with adverse events (AEs) (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead electrocardiogram (ECGs), clinical laboratory parameters, weight, and physical examination.
Time frame: up to 24 hours post dose in each cohort
Safety Endpoints of MAD of RHN-001
Number of subjects with adverse events (AEs) (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead electrocardiogram (ECGs), clinical laboratory parameters, weight, and physical examination.
Time frame: up to 24 hours post dose in each cohort

Secondary outcomes

maximum plasma concentration
maximum concentration of RHN-001 in plasma after dose in each cohort
Time frame: up to 24 hours post dose
Time to reach maximum plasma concentration
Time required for RHN-001 to reach maximum plasma concentration
Time frame: up to 24 hours post dose
AUC (Area under concentration vs time curve)
Area under the time versus plasma RHN-001 concentration curve
Time frame: up to 24 hours post dose

Study locations

1 site

Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS
Karachi, Sindh 75270, Pakistan

References and documents

Individual participant data

Plan to share: No — only de-identified individual participants data can be shared upon proper request to the sponsor.

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05847218
Lead sponsor: RH Nanopharmaceuticals
Collaborators: Center for Bioequivalence Studies and Clinical Research
Responsible party: Sponsor
First posted: May 6, 2023
Start date: Mar 9, 2023
Primary completion: Mar 19, 2023
Completion: Mar 19, 2023
Last update: May 6, 2023

Study contacts

Muhammad Raza Shah, PhD

principal investigator · Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi, Pakistan

Izhar Hasan, MD, PhD

principal investigator · RH Nanopharmaceuticals LLC, Princeton, NJ 088540

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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