SafetyPhase 1NCT05847218

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

A Phase 1 study testing RHN-001 (one tablet 750mg) and RHN-001 (750mg * 2 Tablets) in people with Safety and Tolerability, run by RH Nanopharmaceuticals at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Safety, Tolerability, Pharmacokinetics
What is being tested?: RHN-001 (one tablet 750mg) and RHN-001 (750mg * 2 Tablets)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 sitePakistan
Study dates: 9 Mar 2023to 19 Mar 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

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

Other trials in Pakistan

About this study

Official title: A Single-Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of RHN-001 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: Safety, Tolerability, Pharmacokinetics
Being tested: RHN-001 (one tablet 750mg), RHN-001 (750mg * 2 Tablets)
Keywords: Phase 1 study, Anti inflammatory, healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RHN-001 (one tablet 750mg)Drug
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.
RHN-001 (750mg * 2 Tablets)Drug
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.

Study groups in NCT05847218
Study group	Role	What they receive
Cohort A1 (750mg RHN-001 or Placebo) in fasting state	Experimental	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. Receives: Drug: RHN-001 (one tablet 750mg)
Cohort A2 (750mg RHN-001 or Placebo) in fed state	Experimental	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. Receives: Drug: RHN-001 (one tablet 750mg)
Cohort B1 (1500mg RHN-001 or Placebo) in fasting state	Experimental	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. Receives: Drug: RHN-001 (750mg * 2 Tablets)
Cohort B2 (1500mg RHN-001 or Placebo) in fed state	Experimental	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. Receives: Drug: RHN-001 (750mg * 2 Tablets)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: up to 24 hours post dose in each cohort

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202319 Mar 2023

First posted6 May 2023
Study start9 Mar 2023
Primary completion19 Mar 2023
Study completion19 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SafetyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
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.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05847218
Sponsor's protocol ID: CB-046-RHN(S)-2021
Status last verified: Apr 2023
First submitted: 22 Mar 2023
Last updated: 6 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: only de-identified individual participants data can be shared upon proper request to the sponsor.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of RHN-001 in Healthy Adult Volunteers.
ClinicalTrials.gov ID: NCT05847218
Acronym / sponsor ID: CB-046-RHN(S)-2021
Conditions: Safety, Tolerability, Pharmacokinetics
Keywords: Phase 1 study, Anti inflammatory, healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: RH NanopharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Center for Bioequivalence Studies and Clinical Research
Study start: 9 Mar 2023 (actual)
Primary completion: 19 Mar 2023 (actual)
Study completion: 19 Mar 2023 (actual)
First posted: 6 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4
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.

Arm	Type	Receives
Cohort A1 (750mg RHN-001 or Placebo) in fasting state	Experimental	Drug: RHN-001 (one tablet 750mg)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.
Cohort A2 (750mg RHN-001 or Placebo) in fed state	Experimental	Drug: RHN-001 (one tablet 750mg)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.
Cohort B1 (1500mg RHN-001 or Placebo) in fasting state	Experimental	Drug: RHN-001 (750mg * 2 Tablets)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.
Cohort B2 (1500mg RHN-001 or Placebo) in fed state	Experimental	Drug: RHN-001 (750mg * 2 Tablets)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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Cohort A1 (750mg RHN-001 or Placebo) in fasting state, Cohort A2 (750mg RHN-001 or Placebo) in fed state
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.	Drug	Cohort B1 (1500mg RHN-001 or Placebo) in fasting state, Cohort B2 (1500mg RHN-001 or Placebo) in fed state

Primary outcome

Safety and tolerability profile of SAD of RHN-001
Time frame: up to 24 hours post dose in each cohort
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.
Safety Endpoints of MAD of RHN-001
Time frame: up to 24 hours post dose in each cohort
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.

3 secondary outcomes

maximum plasma concentration
Time frame: up to 24 hours post dose
Time to reach maximum plasma concentration
Time frame: up to 24 hours post dose
AUC (Area under concentration vs time curve)
Time frame: up to 24 hours post dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
Individual participant dataSharing planned: No. only de-identified individual participants data can be shared upon proper request to the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RHN-001 (one tablet 750mg) and RHN-001 (750mg * 2 Tablets) in people with Safety and Tolerability, run by RH Nanopharmaceuticals at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability profile of SAD of RHN-001 (time frame: up to 24 hours post dose in each cohort). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05847218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.