Ascites HepaticPhase 1NCT04384523
A Study of OsrHSA in Adult Healthy Male and Female Volunteers
A Phase 1 study testing OsrHSA 20 mg/kg IV, OsrHSA 40 mg/kg IV and OsrHSA 80 mg/kg IV in people with Ascites Hepatic, run by Healthgen Biotechnology Corp. at 1 site in United States.
Trial summary
A Phase 1 randomized, double blinded, placebo-controlled single dose escalation study of OsrHSA in adult healthy male and female volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ascites Hepatic
- What is being tested?
- OsrHSA 20 mg/kg IV, OsrHSA 40 mg/kg IV and OsrHSA 80 mg/kg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 13 Jul 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must meet all the following criteria to be enrolled in the trial
- Able to understand and willing to sign the ICF
- Healthy male and female subjects, 18-55 years of age, non-smokers, or subjects must have been non-smoking for at least 3 months prior to their screening visit.
- Has adequate venous access
- With no significant medical history, and in good health as determined by detailed medical history (neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease), full physical examination,vital signs, 12-lead electrocardiogram (ECG), urinalysis and laboratory tests at screening. For eligibility purposes, abnormal laboratory or vital signs results may be repeated once if abnormal result is observed at the initial reading. Moreover, abnormalities found in the ECG may need to be confirmed by repeated measurements.
- Subjects must have adequate organ function according to the following laboratory values:
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- Bone marrow function (absolute neutrophil count ≥1500/mm3 and platelet count ≥100,000/mm3)
- Adequate liver function [alanine aminotransferase (ALT) to ≤1.5× upper limit normal (ULN) and alkaline phosphatase to ≤1.5× ULN, total bilirubin ≤1.5 mg/dL]
- Adequate renal function creatinine clearance ≥60 mL/min based on Cockcroft- Gault equation, or serum creatinine level ≤1.5 times the ULN.
- Be a female of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal and have an FSH > 40mIU/mL, or surgically sterile [defined as having a bilateral oophorectomy, hysterectomy or tubal ligation]) or agree to one of the following to prevent pregnancy and, if a woman of childbearing potential, have a negative urine pregnancy test at screening:
- Practicing abstinence
- If a sexually active woman of childbearing potential (sexually active with a non-sterile male partner) agrees to prevent pregnancy by using double methods of contraception as follow until at least 30 days after the administration of the investigational product:
- simultaneous use of intra-uterine contraceptive device, placed at least 4 weeks prior to study drug administration, and condom for the male partner;
- simultaneous use of hormonal contraceptives, starting at least 4 weeks prior to study drug administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner;
- simultaneous use of diaphragm with intravaginally applied spermicide and male condom for the male partner, starting at least 21 days prior to study drug administration.
- Male subjects who are not vasectomized for at least 6 months and who are sexually active with a non-sterile female partner must agree to use double methods of contraception below from the first dose of randomized study drug until 90 days after their dose and must not donate sperm during their study participation period:
- Simultaneous use of a male condom and, for the female partner, hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks);
- Simultaneous use of a male condom and, for the female partner, a diaphragm with intravaginally applied spermicide.
- Body mass index (BMI) 18-30 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Blood pressure ≤ 139/89 mm Hg.
- Subjects are able to follow the study protocol and complete the trial.
- At least 25% of the enrolled subjects will be of Asian descent, defined as Chinese, Japanese, Korean, Vietnamese, Hmong, and their offspring.
Who cannot join
- Subjects who meet any of the following criteria cannot be enrolled:
- History of severe infection within 4 weeks to dosing.
- Signs and symptoms of any active infection regardless of severity within 2 weeks prior to dosing.
- Meals \& Dietary Restrictions: No seafood or high-fat food will be served during confinement in the clinical center
- Subjects who have any history of allergy to food or drug will be excluded ( Including allergies, hypersensitivity, or intolerance to rice or rice products )
- Use of any prescription drugs, herbal supplements, or nonprescription drugs including oral anti-histamines (for seasonal allergies) within 1 month or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplements within 1 week prior to study drug administration, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study. Over-the-counter multivitamins will be permitted. If needed, paracetamol/acetaminophen may be used, but must be documented in the Concomitant medications/Significant non-drug therapies page of the source data. Any questions of concomitant medications should be directed to the Sponsor.
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- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
- Donation of blood 12 week prior to dosing.
- Pregnant, or nursing females.
- A history of substance abuse, psychiatric and psychological condition that, in the judgment of the investigator, may interfere with the planned treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications
- A history of severe allergic reaction to any HpHSA component.
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF interval >450 milliseconds [ms])
- History of or active obstructive disease in biliary tract, liver, kidney and spleen defined by ultrasound.
- Subjects who test positive for hepatitis B or C. (no matter carriers or active will be excluded from the study
- Subjects who test positive for Syphilis, Human immunodeficiency virus (HIV) positive will also be excluded from the study.
- Immunization with a live or attenuated vaccine is prohibited within 4 weeks prior to study drug administration. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed)
- Positive Ig E and Ig G against rice at screening
- History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]) or positive alcohol breath test at screening
- History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening
- Positive urine drug screen, cotinine test, or alcohol breath test at screening
- Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study of OsrHSA in Adult Healthy Male and Female Volunteers
A Phase 1 randomized, double blinded, placebo-controlled single dose escalation study of OsrHSA in adult healthy male and female volunteers
Read the detailed description
This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate safety, tolerability, PK, and immunogenicity of OsrHSA in healthy volunteers.
- Conditions
- Ascites Hepatic
- Being tested
- OsrHSA 20 mg/kg IV, OsrHSA 40 mg/kg IV, OsrHSA 80 mg/kg IV, OsrHSA 140 mg/kg IV, OsrHSA 200 mg/kg IV
- Keywords
- OsrHSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsrHSA 20 mg/kg IVDrug
A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
OsrHSA 40 mg/kg IVDrug
A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
OsrHSA 80 mg/kg IVDrug
A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
OsrHSA 140 mg/kg IVDrug
A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
OsrHSA 200 mg/kg IVDrug
A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
PlaceboOther
Normal Saline (0.9% Sodium Chloride)
| Study group | Role | What they receive |
|---|---|---|
| OsrHSA 20 mg/kg IV | Experimental | Not described Receives: Drug: OsrHSA 20 mg/kg IV; Other: Placebo |
| OsrHSA 40 mg/kg IV | Experimental | Not described Receives: Drug: OsrHSA 40 mg/kg IV; Other: Placebo |
| OsrHSA 80 mg/kg IV | Experimental | Not described Receives: Drug: OsrHSA 80 mg/kg IV; Other: Placebo |
| OsrHSA 140 mg/kg IV | Experimental | Not described Receives: Drug: OsrHSA 140 mg/kg IV; Other: Placebo |
| OsrHSA 200 mg/kg IV | Experimental | Not described Receives: Drug: OsrHSA 200 mg/kg IV; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Measured: from date of Informed Consent through Day 30 (Study Completion)
Secondary outcomes (2)
Maximum Plasma Concentration [Cmax]
Measured: pre-dose, 0.5 hours after dose initiating, EOI (End of Infusion), and 0.5 hours, 4 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), Day 5, Day 8, Day 15, Day 22, and Day 30 post End of Infusion.
Number of Participants With ADA Incident Events
Measured: pre-dose, Day 8, Day 15, Day 22, and Day 30 post End of Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start4 Nov 2019
- Primary completion17 Mar 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ascites HepaticStudies 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
- Sequential
- Model description
- This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study in healthy volunteers to evaluate safety, tolerability, PK, PD and immunogenicity of OsrHSA.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthgen Biotechnology Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Nguyen, MD, MBA, Principal investigator, WCCT Global, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384523
- Sponsor's protocol ID
- US-HY1001
- Status last verified
- May 2021
- First submitted
- 13 Apr 2020
- Last updated
- 1 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study of OsrHSA in Adult Healthy Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT04384523
- Acronym / sponsor ID
- US-HY1001
- Conditions
- Ascites Hepatic
- Keywords
- OsrHSA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Healthgen Biotechnology Corp.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Posted 1 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 randomized, double blinded, placebo-controlled single dose escalation study of OsrHSA in adult healthy male and female volunteers
Detailed description
This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate safety, tolerability, PK, and immunogenicity of OsrHSA in healthy volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study in healthy volunteers to evaluate safety, tolerability, PK, PD and immunogenicity of OsrHSA.
| Arm | Type | Receives |
|---|---|---|
| OsrHSA 20 mg/kg IV | Experimental | Drug: OsrHSA 20 mg/kg IV, Other: Placebo |
| OsrHSA 40 mg/kg IV | Experimental | Drug: OsrHSA 40 mg/kg IV, Other: Placebo |
| OsrHSA 80 mg/kg IV | Experimental | Drug: OsrHSA 80 mg/kg IV, Other: Placebo |
| OsrHSA 140 mg/kg IV | Experimental | Drug: OsrHSA 140 mg/kg IV, Other: Placebo |
| OsrHSA 200 mg/kg IV | Experimental | Drug: OsrHSA 200 mg/kg IV, Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- Subjects must meet all the following criteria to be enrolled in the trial
- Able to understand and willing to sign the ICF
- Healthy male and female subjects, 18-55 years of age, non-smokers, or subjects must have been non-smoking for at least 3 months prior to their screening visit.
- Has adequate venous access
- With no significant medical history, and in good health as determined by detailed medical history (neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease), full physical examination,vital signs, 12-lead electrocardiogram (ECG), urinalysis and laboratory tests at screening. For eligibility purposes, abnormal laboratory or vital signs results may be repeated once if abnormal result is observed at the initial reading. Moreover, abnormalities found in the ECG may need to be confirmed by repeated measurements.
Key exclusion criteria (21 listed)
- History of severe infection within 4 weeks to dosing.
- Signs and symptoms of any active infection regardless of severity within 2 weeks prior to dosing.
- Meals \& Dietary Restrictions: No seafood or high-fat food will be served during confinement in the clinical center
- Subjects who have any history of allergy to food or drug will be excluded ( Including allergies, hypersensitivity, or intolerance to rice or rice products )
- Use of any prescription drugs, herbal supplements, or nonprescription drugs including oral anti-histamines (for seasonal allergies) within 1 month or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplements within 1 week prior to study drug administration, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study. Over-the-counter multivitamins will be permitted. If needed, paracetamol/acetaminophen may be used, but must be documented in the Concomitant medications/Significant non-drug therapies page of the source data. Any questions of concomitant medications should be directed to the Sponsor.
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 |
|---|---|---|
| OsrHSA 20 mg/kg IVA single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min | Drug | OsrHSA 20 mg/kg IV |
| OsrHSA 40 mg/kg IVA single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min | Drug | OsrHSA 40 mg/kg IV |
| OsrHSA 80 mg/kg IVA single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min | Drug | OsrHSA 80 mg/kg IV |
| OsrHSA 140 mg/kg IVA single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min | Drug | OsrHSA 140 mg/kg IV |
| OsrHSA 200 mg/kg IVA single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min | Drug | OsrHSA 200 mg/kg IV |
| PlaceboNormal Saline (0.9% Sodium Chloride) | Other | OsrHSA 140 mg/kg IV, OsrHSA 20 mg/kg IV, OsrHSA 200 mg/kg IV, OsrHSA 40 mg/kg IV, OsrHSA 80 mg/kg IV |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: from date of Informed Consent through Day 30 (Study Completion)
2 secondary outcomes
Maximum Plasma Concentration [Cmax]
Time frame: pre-dose, 0.5 hours after dose initiating, EOI (End of Infusion), and 0.5 hours, 4 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), Day 5, Day 8, Day 15, Day 22, and Day 30 post End of Infusion.
Number of Participants With ADA Incident Events
Time frame: pre-dose, Day 8, Day 15, Day 22, and Day 30 post End of Infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David Nguyen, MD, MBA principal investigator
WCCT Global, Inc
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 OsrHSA 20 mg/kg IV, OsrHSA 40 mg/kg IV and OsrHSA 80 mg/kg IV in people with Ascites Hepatic, run by Healthgen Biotechnology Corp. 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 22 inclusion and 21 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 1 Jun 2021. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: from date of Informed Consent through Day 30 (Study Completion)). 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 1 Jun 2021.