Clinical trial NCT05847218: Phase 1 Clinical Trial of RHN-001 in Healthy Adult Volunteers
Official title: A Single-Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of RHN-001 in Healthy Adult Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Tolerability
Pharmacokinetics
Keywords: Phase 1 study
Anti inflammatory
healthy volunteers
Lead sponsor: RH Nanopharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Center for Bioequivalence Studies and Clinical Research
First posted: 2023-05-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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., single oral dose of investigational drug 750 mg or placebo under fasting (Cohort A1) and 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., single oral dose of 1500 mg or placebo under fasting (Cohort B1) and single oral dose of 1500 mg or placebo under fed conditions (Cohort B2). The second phase of the study will be carried out after the safety assessments of period one.

Blood and urine samples will be collected from volunteers till 24 hours post dose in each Cohort for pharmacokinetic assessment of the drug and its active metabolites.
Primary purpose: OTHER

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 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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Safety and tolerability profile of SAD of RHN-001
timeFrame: up to 24 hours post dose in each cohort
measure: Safety Endpoints of MAD of RHN-001
timeFrame: up to 24 hours post dose in each cohort
Secondary outcomes:
measure: maximum plasma concentration
timeFrame: up to 24 hours post dose
measure: Time to reach maximum plasma concentration
timeFrame: up to 24 hours post dose
measure: AUC (Area under concentration vs time curve)
timeFrame: up to 24 hours post dose
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS
state: Sindh
Study officials:
affiliation: Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi, Pakistan
name: Muhammad Raza Shah, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RH Nanopharmaceuticals LLC, Princeton, NJ 088540
name: Izhar Hasan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: