HealthyPhase 1NCT05166096
Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects
A Phase 1 study testing Rho-11 and aspirin 325mg in people with Healthy, run by Rhoshan Pharmaceuticals Inc at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety, pharmacokinetics, and pharmacodynamic effects of aspirin administered intravenously with aspirin administered orally. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rho-11 and aspirin 325mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2021to 11 May 2022
- 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
- Each subject must meet all of the following criteria to be enrolled in this study:
- The subject is male or female 18 to 55 years of age, inclusive
- The subjects has a body mass index (BMI) 18 to 30 kg/m2, inclusive, at screening.
- The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
- The subject has a hemoglobin level within following acceptable range at Screening and Check-in: Male: 12.8 to 17.4 g/dL, Female: 10.8 to 15.0 g/dL
- The subject has liver function tests within normal limits, or has results that do not show clinically significant abnormalities, as judged by the investigator at Screening and Check in.
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- The subject has estimated glomerular filtration rate (eGFR) ≥ 50 mL/min at Screening.
- Female subjects of childbearing potential must use an acceptable method of birth control (i.e., diaphragm with spermicide, intrauterine device, condom with foam or vaginal spermicide, oral contraceptives, or abstinence) or be surgically sterile (i.e., hysterectomy, bilateral tubal ligation or bilateral oophorectomy), or postmenopausal (defined as amenorrhea 12 consecutive months and documented plasma FSH level >40 IU/mL). Female subjects must have a negative pregnancy test at screening and before dosing with study drug.
- Male subjects with female partners of childbearing potential must be vasectomized, be willing to use an acceptable method of birth control, or to practice abstinence during the study.
- The subject agrees to comply with all protocol requirements.
- The subject is able to provide written informed consent.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- The subjects has had any major illness within 3 months before dosing with study drug or any significant ongoing chronic medical illness, as judged by the investigator.
- The subjects has a history of active deep vein thrombosis and/or thromboembolic disorder, including history of hypothrombinemia and vitamin K deficiency.
- The subject has a history of neuropsychiatric disease, hypertension, cardiac failure, cerebrovascular disease, chronic respiratory disease, asthma, nasal polyps associated with asthma, hepatic or renal impairment, recent dehydration (within last 30 days), gout thyrotoxicosis or systemic lupus erythematosus and other connective tissue disorders.
- The subject has a history of gastrointestinal bleeding or has active gastrointestinal disease that could affect drug absorption.
- The subject has a history of hemorrhagic disorder.
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- Prothrombin time or activated partial thromboplastin time level outside the normal range at screening and check-in.
- The subject has an increased risk of bleeding including but not limited to: any history of a clinically significant bleeding problem, any recent (within 30 days preceding the first dose of study drug) major trauma, platelet count <100,000 mm3
- The subject has a history of glucose-6-phosphate dehydrogenase deficiency.
- The subject has a recent history of tooth extraction within 3 weeks before dosing with study drug.
- The subject is a smoker or has used nicotine-containing products (e.g., snuff, nicotine patch, nicotine chewing gum, mock cigarettes, inhalers, or "vape" devices) within 6 months before the first dose of study drug and throughout the study (including the washout period).
- The subject has a history of alcohol abuse or drug addiction within 1 year prior to check-in or excessive alcohol consumption (regular alcohol intake >21 units per week for male subjects and >14 units of alcohol per week for female subjects), or use of alcohol 48 hours before dosing with study drug.
- The subject has a positive test result for drugs of abuse, alcohol, or cotinine at screening or before dosing with study drug.
- The subject has used any prescription (excluding hormonal birth control) or over-the-counter medications, including fish oil and other herbal or nutritional supplements and, in particular, aspirin (no aspirin-containing medications allowed at all), nonsteroidal anti-inflammatory agents (No NSAIDS allowed at all, and no acetaminophen, diclofenac, ketorolac allowed), or anticoagulation therapy within 14 days before dosing with study drug and throughout the entire study period (including the washout period).
- The subject has received vaccination against Varicella zoster within 6 weeks before dosing with study drug.
- The subject has a positive test result for COVID-19, hepatitis B surface antigen, hepatitis C virus antibody, or HIV type 1 or 2 antibodies at screening.
- The subject has received the COVID-19 vaccine within 14 days before Day -3, or subjects who plan to receive a COVID-19 vaccine at any time during the study.
- The subject has a history of relevant drug and/or food allergies (i.e., allergy to aspirin or any excipients, allergic skin reactions, or any significant food allergy that could preclude a standard diet in the clinical unit).
- The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containing products (e.g. marmalade), or alcohol-, caffeine-, poppy-, or xanthine-containing products within 48 hours.
- The subject is involved in strenuous activity or contact sports within 24 hours before dosing with study drug and during the study.
- The subject has donated blood or blood products >450 mL within 30 days before dosing with study drug.
- The subject has received study drug in another investigational study within 30 days or 5 half-lives, whichever is longer, before dosing with study drug.
- In the opinion of the investigator, the subject is not suitable for entry into the study.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, 2-Period, 2-Formulation, Within-Subject Crossover Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects Under Fasting Conditions
The purpose of this study is to compare the safety, pharmacokinetics, and pharmacodynamic effects of aspirin administered intravenously with aspirin administered orally.
- Conditions
- Healthy
- Being tested
- Rho-11, aspirin 325mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rho-11Drug
Also called Intravenous aspirin
Subjects will be administered 325 mg aspirin by rapid IV push
aspirin 325mgDrug
Subjects will be administered 325 mg aspirin orally
| Study group | Role | What they receive |
|---|---|---|
| Rho-11 administered in Period 1, oral aspirin administered in Period 2 | Experimental | Not described Receives: Drug: Rho-11; Drug: aspirin 325mg |
| Oral aspirin administered in Period 1, Rho-11 administered in Period 2 | Experimental | Not described Receives: Drug: Rho-11; Drug: aspirin 325mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum thromboxane B2 from baseline
Change in serum thromboxane B2 from baseline to 180 minutes post treatment
Measured: 1 hour before dosing and 2, 5, 10, 20, 30,45, 60, and 180 minutes post dosing
Secondary outcomes (4)
Urinary 11-dehydro-TXB2 levels
Measured levels of 11-dehydro-TXB2 in urine following treatment
Measured: Every 12 hours from 72 hours prior to dosing to 72 hours after dosing.
Urinary 2,3-dinor-6-keto-PGF1alpha
Measured levels of 2,3-dinor-6-keto-PGF1alpha in urine following treatment
Measured: Every 12 hours from 72 hours prior to dosing to 72 hours after dosing.
Acetylsalicylic Acid Plasma Pharmacokinetics
Measured change in levels of acetylsalicylic acid in plasma following treatment
Measured: 1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours post-dosing.
Salicylic Acid Plasma Pharmacokinetics
Measured change in levels of salicylic acid in plasma following treatment
Measured: 1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours post-dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start3 Dec 2021
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhoshan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166096
- Sponsor's protocol ID
- RHO-11-002
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 2-Period, 2-Formulation, Within-Subject Crossover Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT05166096
- Acronym / sponsor ID
- RHO-11-002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rhoshan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 21 Dec 2021 (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.
The purpose of this study is to compare the safety, pharmacokinetics, and pharmacodynamic effects of aspirin administered intravenously with aspirin administered orally.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rho-11 administered in Period 1, oral aspirin administered in Period 2 | Experimental | Drug: Rho-11, Drug: aspirin 325mg |
| Oral aspirin administered in Period 1, Rho-11 administered in Period 2 | Experimental | Drug: Rho-11, Drug: aspirin 325mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- The subject is male or female 18 to 55 years of age, inclusive
- The subjects has a body mass index (BMI) 18 to 30 kg/m2, inclusive, at screening.
- The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
- The subject has a hemoglobin level within following acceptable range at Screening and Check-in: Male: 12.8 to 17.4 g/dL, Female: 10.8 to 15.0 g/dL
- The subject has liver function tests within normal limits, or has results that do not show clinically significant abnormalities, as judged by the investigator at Screening and Check in.
Key exclusion criteria (24 listed)
- The subjects has had any major illness within 3 months before dosing with study drug or any significant ongoing chronic medical illness, as judged by the investigator.
- The subjects has a history of active deep vein thrombosis and/or thromboembolic disorder, including history of hypothrombinemia and vitamin K deficiency.
- The subject has a history of neuropsychiatric disease, hypertension, cardiac failure, cerebrovascular disease, chronic respiratory disease, asthma, nasal polyps associated with asthma, hepatic or renal impairment, recent dehydration (within last 30 days), gout thyrotoxicosis or systemic lupus erythematosus and other connective tissue disorders.
- The subject has a history of gastrointestinal bleeding or has active gastrointestinal disease that could affect drug absorption.
- The subject has a history of hemorrhagic disorder.
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 |
|---|---|---|
| Rho-11Also: Intravenous aspirinSubjects will be administered 325 mg aspirin by rapid IV push | Drug | Oral aspirin administered in Period 1, Rho-11 administered in Period 2, Rho-11 administered in Period 1, oral aspirin administered in Period 2 |
| aspirin 325mgSubjects will be administered 325 mg aspirin orally | Drug | Oral aspirin administered in Period 1, Rho-11 administered in Period 2, Rho-11 administered in Period 1, oral aspirin administered in Period 2 |
Primary outcome
Change in serum thromboxane B2 from baseline
Time frame: 1 hour before dosing and 2, 5, 10, 20, 30,45, 60, and 180 minutes post dosing
Change in serum thromboxane B2 from baseline to 180 minutes post treatment
4 secondary outcomes
Urinary 11-dehydro-TXB2 levels
Time frame: Every 12 hours from 72 hours prior to dosing to 72 hours after dosing.
Urinary 2,3-dinor-6-keto-PGF1alpha
Time frame: Every 12 hours from 72 hours prior to dosing to 72 hours after dosing.
Acetylsalicylic Acid Plasma Pharmacokinetics
Time frame: 1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours post-dosing.
Salicylic Acid Plasma Pharmacokinetics
Time frame: 1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours post-dosing.
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 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rho-11 and aspirin 325mg in people with Healthy, run by Rhoshan Pharmaceuticals Inc at 1 site in United States.
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 11 inclusion and 24 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 12 Aug 2026. 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 United States. 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?
Change in serum thromboxane B2 from baseline (time frame: 1 hour before dosing and 2, 5, 10, 20, 30,45, 60, and 180 minutes post dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.