Healthy VolunteersPhase 1NCT03546465
Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects
A Phase 1 study testing ropeginterferon alfa-2b in people with Healthy Volunteers, run by PharmaEssentia Japan K.K. at 1 site in Australia.
Trial summary
This is a Phase 1 single center, parallel group study to assess and compare the safety, tolerability, PK and PD of 4 single ascending doses of P1101 (100, 200, 300, and 450 μg) following subcutaneous administration in healthy Japanese and Caucasian subjects. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ropeginterferon alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- 7 May 2018to 15 Jul 2019
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects are eligible to be included in the study only if all of the following criteria apply:
- Adult Japanese and Caucasian males aged 21 to 50 years inclusive and body mass index (BMI) between 19 and 30 kg/m2.
- Japanese subjects must be first generation (born in Japan) with parents and grandparents born in Japan, lived for < 10 years outside of Japan, and have no significant change in life style since leaving Japan.
- Caucasian subjects must have both parents of Caucasian descent; Caucasian subjects are defined as descendants of the original peoples of Europe.
- Individual Caucasian subjects should be selected to match body weight (± 20%) and height (± 15%) of corresponding Japanese subjects.
- Subjects must be willing to use effective methods of contraception during the entire study period and for 12 weeks after dosing on Day 1.
Show all 13Show fewer
- Subjects who are healthy as determined by pre-study medical history, physical examination, and 12-lead ECG.
- Subjects whose clinical laboratory test results are within the reference ranges for hematological parameters and liver function tests at Screening and Day -1. For results outside the reference range at Screening and considered not clinically significant by the Investigator a repeat test is allowed once during the Screening period. Note: subjects with an absolute neutrophil count below 2.0 × 109/L will be excluded. All other clinical laboratory test results must be within the reference range or judged not to be clinically significant and acceptable to the Investigator.
- Subjects whose thyroid function tests are within the study reference range.
- Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCVAb) and human immunodeficiency virus (HIV) I and II tests at Screening.
- Subjects who are negative for drugs of abuse and alcohol tests at Screening. Alcohol will be measured using breathalyzer test. If the tests are negative at Screening, and if they meet other eligibility criteria, the subject may be included. A repeat test for suspected false positive at Screening (with documented rationale) may be performed at the discretion of the Investigator. However, if the tests are subsequently positive on Admission, the subject should be withdrawn from the study. Repeat tests are not allowed at Admission.
- Subjects who are non-smokers for at least 6 months preceding Screening.
- Subjects who are able and willing to give a valid written informed consent.
Who cannot join
- Subjects are excluded from the study if any of the following criteria apply:
- Subjects who do not conform to the above inclusion criteria.
- Female subjects.
- Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, coagulation, endocrine, lymphatic, neurological, cardiovascular, psychiatric, ophthalmological, musculoskeletal, genitourinary, immunological, autoimmune, dermatological, and connective tissue diseases or disorders.
- Subjects who have a first degree relative with autoimmune disease (e.g. thyroiditis, lupus, rheumatoid arthritis, etc.) or other clinically relevant medical history which in the opinion of the Investigator poses a risk to the subject.
- Subjects with a history of latent or active tuberculosis or exposure to endemic areas.
Show all 37Show fewer
- Subjects with a positive result in the QuantiFERON-TB Gold test and/or clinically significant abnormality on chest X-ray.
- Subjects who have a clinically relevant surgical history and history of any prior malignancy.
- Subjects who, in the opinion of the Investigator, have clinically relevant medical history in their immediate family (first degree relative).
- Subjects with current symptoms of eczema or hay fever, or subjects with a history of hay fever requiring medication when their hay fever season starts within the expected duration of the study.
- Subjects who have a history of severe allergy and severe drug reaction (e.g., anaphylaxis, or other drug reaction requiring hospitalization to beta lactam antibiotics OR any other relevant drug hypersensitivity).
- Subjects who have a history of alcoholism.
- Subjects who consume more than the recommended number of 14 units of alcohol per week. (1 unit = 1 glass of wine [125 mL] = 1 measure of spirits = ½ pint of beer).
- Subjects who have a history of drug abuse.
- Subjects who have abnormal vital signs, after 10 minutes supine rest (measurements may be repeated after 15 minutes at the discretion of the Investigator where they suspect that the initial values are not representative of the usual values due to some factors e.g., anxiety), defined as any of the following at Screening:
- Systolic blood pressure < 90 mmHg or ≥ 140 mmHg;
- Diastolic blood pressure < 50 mmHg or ≥ 90 mmHg;
- Pulse rate < 40 or > 100 beats per minute.
- Subjects who have any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes.
- Subjects who have a prolonged QTcF > 450 ms or family history of long QT syndrome.
- Subjects who have a significant infection such as a respiratory infection or known inflammatory process at Screening or Admission.
- Subjects who have a clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection within the 30 days prior to Admission (e.g., common cold, viral syndrome, flu-like symptoms, etc).
- Subjects who have acute gastrointestinal symptoms at Screening or Admission (e.g., nausea, vomiting, diarrhea, and heartburn).
- Subjects who have used 1 or more prescription drugs within 28 days prior to Day 1.
- Subjects who have used non-prescription drugs or other products (supplements, herbal preparations, etc) with enzyme inducing properties such as St John's Wort within 28 days prior to the first administration of investigational product.
- Subjects who have used other non-prescription drugs excluding routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first administration of investigational product, unless agreed as not clinically relevant by the Principal Investigator and Sponsor.
- Subjects who have received any live vaccine in the 6 months prior to Screening.
- Subjects who have previously been exposed to interferon or peginterferon.
- Subjects who have received the last dose of investigational product within the last 3 months or within 5 times the half-life, whichever is longer and those who are on extended follow-up.
- Subjects who are vegans or have medical dietary restrictions.
- Subjects who have consumed grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of investigational product.
- Subjects who have donated blood/plasma within 3 months of Screening or who have had any blood loss > 500 mL during the 3 months prior to Screening.
- Subjects who are staff members at the investigational site.
- Subjects who are Contract Research Organization staff members, Sponsor employees, and affiliates.
- Subjects who cannot understand or communicate reliably with the Investigator.
- Subjects who are unlikely to co-operate with the requirements of the study.
- Subjects who have been shown to have a suicidal tendency following completion of the C-SSRS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Bridging Study to Investigate and Compare the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Four Single Ascending Doses of Ropeginterferon Alfa-2b (P1101) in Healthy Japanese and Healthy Caucasian Subjects
This is a Phase 1 single center, parallel group study to assess and compare the safety, tolerability, PK and PD of 4 single ascending doses of P1101 (100, 200, 300, and 450 μg) following subcutaneous administration in healthy Japanese and Caucasian subjects.
Read the detailed description
Twenty-four healthy eligible Japanese male subjects and 24 healthy eligible Caucasian male subjects, each divided into 4 cohorts of 6 subjects, will participate in this study. No subject will participate in more than 1 cohort and all subjects will receive a single dose of P1101. Caucasian subjects will be body weight- and height-matched to Japanese subjects.
Dosing will be initiated with the lowest dose of 100 μg in both Japanese and Caucasian subjects.
- Conditions
- Healthy Volunteers
- Being tested
- ropeginterferon alfa-2b
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropeginterferon alfa-2bDrug
Also called P1101
6 subjects in each cohort will receive a single dose by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohorts 1C (Caucasian subjects) | Experimental | ropeginterferon alfa-2b: single dose of 100 μg Receives: Drug: ropeginterferon alfa-2b |
| Cohorts 1J (Japanese subjects) | Experimental | ropeginterferon alfa-2b: single dose of 100 μg Receives: Drug: ropeginterferon alfa-2b |
| Cohorts 2C (Caucasian subjects) | Experimental | ropeginterferon alfa-2b: single dose of 200 μg Receives: Drug: ropeginterferon alfa-2b |
| Cohorts 2J (Japanese subjects) | Experimental | ropeginterferon alfa-2b: single dose of 200 μg Receives: Drug: ropeginterferon alfa-2b |
| Cohorts 3C (Caucasian subjects) | Experimental | ropeginterferon alfa-2b: single dose of 300 μg Receives: Drug: ropeginterferon alfa-2b |
| Cohorts 3J (Japanese subjects) | Experimental | ropeginterferon alfa-2b: single dose of 300 μg Receives: Drug: ropeginterferon alfa-2b |
| Cohorts 4C (Caucasian subjects) | Experimental | ropeginterferon alfa-2b: single dose of 450 μg Receives: Drug: ropeginterferon alfa-2b |
| Cohorts 4J (Japanese subjects) | Experimental | ropeginterferon alfa-2b: single dose of 450 μg Receives: Drug: ropeginterferon alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events after single dose
Frequency and severity of all adverse events among subjects, including frequency and severity of drug-related adverse events.
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-last)]
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity [AUC(0-inf)]
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Observed maximum plasma concentration [Cmax]
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time to reach Cmax [tmax]
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
apparent terminal rate constant
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Apparent terminal half-life [t½]
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Apparent systemic clearance [CL/F]
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
apparent volume of distribution during the terminal phase [Vz/F]
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
dose normalized AUC(0-last) [AUC(0-last)/Dose]
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
dose normalized AUC(0-inf) [AUC(0-inf)/Dose]
Measured: Through study Day 35
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Dose normalized Cmax [Cmax/Dose]
Measured: Through study Day 35
Secondary outcomes (6)
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Beta-2 microglobulin: maximum serum biomarker response [Emax]
Measured: Through study Day 35
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Beta-2 microglobulin: time to Emax [TEmax]
Measured: Through study Day 35
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Beta-2 microglobulin: area under the serum biomarker effect-time curve [AUEC(0-t)]
Measured: Through study Day 35
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Neopterin: maximum serum biomarker response [Emax]
Measured: Through study Day 35
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Neopterin: time to Emax [TEmax]
Measured: Through study Day 35
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Neopterin: area under the serum biomarker effect-time curve [AUEC(0-t)]
Measured: Through study Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start7 May 2018
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEssentia Japan K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaEssentia
- Responsible party
- Sponsor
- Investigators
- Jason Lickliter, MD, Principal investigator, Nucleus Network Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546465
- Sponsor's protocol ID
- A17-102
- Status last verified
- Nov 2019
- First submitted
- 6 May 2018
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Qin A, Shimoda K, Suo S, Fu R, Kirito K, Wu D, Liao J, Chen H, Wu L, Su X, Gao Y, Sato T, Li Y, Zhang J, Shen W, Wang W, Zhang L, Jin J, Komatsu N. Population Pharmacokinetics-Pharmacodynamics and Exposure-Response of Ropeginterferon Alfa-2b in Chinese and Japanese Patients With Polycythemia Vera. Pharmacol Res Perspect. 2025 Jun;13(3):e70109. doi: 10.1002/prp2.70109.
PubMed 40313042Miyachi N, Zagrijtschuk O, Kang L, Yonezu K, Qin A. Pharmacokinetics and Pharmacodynamics of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects After Single Subcutaneous Administration. Clin Drug Investig. 2021 Apr;41(4):391-404. doi: 10.1007/s40261-021-01026-5. Epub 2021 Mar 16.
PubMed 33725322
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Bridging Study to Investigate and Compare the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Four Single Ascending Doses of Ropeginterferon Alfa-2b (P1101) in Healthy Japanese and Healthy Caucasian Subjects
- ClinicalTrials.gov ID
- NCT03546465
- Acronym / sponsor ID
- A17-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PharmaEssentia Japan K.K.Industry (pharma, biotech, devices)
- Collaborators
- PharmaEssentia
- Study start
- 7 May 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 6 Jun 2018 (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.
This is a Phase 1 single center, parallel group study to assess and compare the safety, tolerability, PK and PD of 4 single ascending doses of P1101 (100, 200, 300, and 450 μg) following subcutaneous administration in healthy Japanese and Caucasian subjects.
Detailed description
Twenty-four healthy eligible Japanese male subjects and 24 healthy eligible Caucasian male subjects, each divided into 4 cohorts of 6 subjects, will participate in this study. No subject will participate in more than 1 cohort and all subjects will receive a single dose of P1101. Caucasian subjects will be body weight- and height-matched to Japanese subjects.
Dosing will be initiated with the lowest dose of 100 μg in both Japanese and Caucasian subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohorts 1C (Caucasian subjects) | Experimental | Drug: ropeginterferon alfa-2bropeginterferon alfa-2b: single dose of 100 μg |
| Cohorts 1J (Japanese subjects) | Experimental | Drug: ropeginterferon alfa-2bropeginterferon alfa-2b: single dose of 100 μg |
| Cohorts 2C (Caucasian subjects) | Experimental | Drug: ropeginterferon alfa-2bropeginterferon alfa-2b: single dose of 200 μg |
| Cohorts 2J (Japanese subjects) | Experimental | Drug: ropeginterferon alfa-2bropeginterferon alfa-2b: single dose of 200 μg |
| Cohorts 3C (Caucasian subjects) | Experimental | Drug: ropeginterferon alfa-2bropeginterferon alfa-2b: single dose of 300 μg |
| Cohorts 3J (Japanese subjects) | Experimental | Drug: ropeginterferon alfa-2bropeginterferon alfa-2b: single dose of 300 μg |
| Cohorts 4C (Caucasian subjects) | Experimental | Drug: ropeginterferon alfa-2bropeginterferon alfa-2b: single dose of 450 μg |
| Cohorts 4J (Japanese subjects) | Experimental | Drug: ropeginterferon alfa-2bropeginterferon alfa-2b: single dose of 450 μg |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subjects are eligible to be included in the study only if all of the following criteria apply:
- Adult Japanese and Caucasian males aged 21 to 50 years inclusive and body mass index (BMI) between 19 and 30 kg/m2.
- Japanese subjects must be first generation (born in Japan) with parents and grandparents born in Japan, lived for < 10 years outside of Japan, and have no significant change in life style since leaving Japan.
- Caucasian subjects must have both parents of Caucasian descent; Caucasian subjects are defined as descendants of the original peoples of Europe.
- Individual Caucasian subjects should be selected to match body weight (± 20%) and height (± 15%) of corresponding Japanese subjects.
Key exclusion criteria (37 listed)
- Subjects who do not conform to the above inclusion criteria.
- Female subjects.
- Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, coagulation, endocrine, lymphatic, neurological, cardiovascular, psychiatric, ophthalmological, musculoskeletal, genitourinary, immunological, autoimmune, dermatological, and connective tissue diseases or disorders.
- Subjects who have a first degree relative with autoimmune disease (e.g. thyroiditis, lupus, rheumatoid arthritis, etc.) or other clinically relevant medical history which in the opinion of the Investigator poses a risk to the subject.
- Subjects with a history of latent or active tuberculosis or exposure to endemic areas.
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 |
|---|---|---|
| ropeginterferon alfa-2bAlso: P11016 subjects in each cohort will receive a single dose by subcutaneous injection | Drug | Cohorts 1C (Caucasian subjects), Cohorts 1J (Japanese subjects), Cohorts 2C (Caucasian subjects), Cohorts 2J (Japanese subjects), Cohorts 3C (Caucasian subjects), Cohorts 3J (Japanese subjects), Cohorts 4C (Caucasian subjects), Cohorts 4J (Japanese subjects) |
Primary outcome
Adverse events after single dose
Time frame: Through study Day 35
Frequency and severity of all adverse events among subjects, including frequency and severity of drug-related adverse events.
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-last)]
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Area under the plasma concentration-time curve from time zero extrapolated to infinity [AUC(0-inf)]
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Observed maximum plasma concentration [Cmax]
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Time to reach Cmax [tmax]
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
apparent terminal rate constant
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Apparent terminal half-life [t½]
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Apparent systemic clearance [CL/F]
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
apparent volume of distribution during the terminal phase [Vz/F]
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
dose normalized AUC(0-last) [AUC(0-last)/Dose]
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
dose normalized AUC(0-inf) [AUC(0-inf)/Dose]
Pharmacokinetics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Dose normalized Cmax [Cmax/Dose]
6 secondary outcomes
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
Pharmacodynamics of ropeginterferon alfa-2b after single dose
Time frame: Through study Day 35
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 26 Nov 2019.
- Derived from this study: PubMed 40313042Qin A, Shimoda K, Suo S, Fu R, Kirito K, Wu D, Liao J, Chen H, Wu L, Su X, Gao Y, Sato T, Li Y, Zhang J, Shen W, Wang W, Zhang L, Jin J, Komatsu N. Population Pharmacokinetics-Pharmacodynamics and Exposure-Response of Ropeginterferon Alfa-2b in Chinese and Japanese Patients With Polycythemia Vera. Pharmacol Res Perspect. 2025 Jun;13(3):e70109. doi: 10.1002/prp2.70109.
- Derived from this study: PubMed 33725322Miyachi N, Zagrijtschuk O, Kang L, Yonezu K, Qin A. Pharmacokinetics and Pharmacodynamics of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects After Single Subcutaneous Administration. Clin Drug Investig. 2021 Apr;41(4):391-404. doi: 10.1007/s40261-021-01026-5. Epub 2021 Mar 16.
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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.
Jason Lickliter, MD principal investigator
Nucleus Network Ltd
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 ropeginterferon alfa-2b in people with Healthy Volunteers, run by PharmaEssentia Japan K.K. at 1 site in Australia.
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 13 inclusion and 37 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 26 Nov 2019. 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 Australia. 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?
Adverse events after single dose (time frame: Through study Day 35). The study lists 12 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 NCT03546465, which also lists 2 linked publications.
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 26 Nov 2019.