Healthy SubjectsPhase 1NCT06630494
Phase I Study to Evaluate rhTPO in Healthy Caucasian Volunteers
A Phase 1 study testing Recombinant human thrombopoietin for injection (rhTPO) in people with Healthy Subjects, run by 3SBIO AU PTY LTD at 1 site in Australia.
Trial summary
This is a single-center, single-arm, open-label, single-dose phase I clinical study to evaluate pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of Recombinant Human Thrombopoietin for Injection (rhTPO) in healthy Caucasian participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Recombinant human thrombopoietin for injection (rhTPO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Oct 2024to 17 Dec 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Healthy Caucasian adult male and female participants aged 18-50 years (inclusive) at the time of informed consent. Caucasian is defined as of European, Middle Eastern, or North African descent.
- Male participants weighing no less than 50 kg. Female participants should not weigh less than 45 kg.
- Body mass index (BMI) within the range 18.0 to 32.0 kg/m2 (inclusive). Note: BMI = weight [kg] / (height [m])2
- Participants are in good general health as determined by the investigator, based on a medical evaluation including medical history, vital signs, physical examination, 12-lead electrocardiogram, clinical safety laboratory tests; Note: Any results outside of the reference range at screening or baseline may be repeated once per the Investigator's discretion for the purpose of further determining eligibility.
- Platelet counts must be within the normal range; measurements can repeat once for verification, if necessary.
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- Women of childbearing potential (WOCBP, see section 5.3.3) must have a negative serum or urine pregnancy test prior to the start of study drug and must not be breastfeeding, lactating or planning pregnancy during the study period. WOCBP who are not exclusively in same-sex relationships and males with partners of child-bearing potential must agree to use adequate contraception from signing the informed consent until 3 months after completion of the study. In addition, females must not donate ova (eggs) and males must not donate sperm from signing the informed consent until 3 months after completion of the study;
- Negative for COVID-19 based on the nasopharyngeal or oropharyngeal swab with the method of real-time reverse transcription-polymerase chain reaction (RT-PCR) at Screening and Day-1.
- Volunteer to participate in this study, be able to understand and comply with the clinical study protocol requirements, and sign the informed consent form in writing.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- History of hypersensitivity to components of study drug or analogs; history of anaphylaxis or other significant allergy in opinion of the investigators.
- Known allergy to heparin or history of heparin-induced thrombocytopenia;
- Received a platelet transfusion within 2 weeks or platelet-boosting medication within 4 weeks prior to dosing;
- History of hospitalization or surgical procedure within 3 months prior to dosing, or bleeding from trauma or internal bleeding greater than 100 mL, or donating more than 100 mL of blood;
- History or presence of autoimmune disease, malignancy, thromboembolic disease, bleeding disorders, cardiovascular, hepatic, renal, muscular, hematopoietic, respiratory, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when taking the study drug; or interfering with the interpretation of data judged by the investigator; Note: Uncomplicated cholecystectomy and appendectomy are permitted; History of fully resolved childhood asthma is not permitted.
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- History or presence of chronic diseases such as hypertension and diabetes (including type 1 and type 2 diabetes);
- History of malignancy with the exception of successfully treated basal cell or squamous cell skin cancer with no evidence of recurrence for 5 years.
- History of platelet clumping that prevents reliable measurement of platelet counts;
- Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C Virus (HCV) antibody and Human Immunodeficiency Virus (HIV) antibody, Syphilis antibody; Note: Participants with positive hepatitis C antibody can be enrolled if a confirmatory negative hepatitis C RNA test is obtained.
- Immunization with a Corona Virus Disease 2019 (COVID-19) vaccine 14 days prior to dosing or planned vaccination within 30 days after dosing
- Use of prescription medication within 14 days prior to dosing and 7 days prior to dosing for over the counter medication/vitamins/herbal supplements (with the exception of contraception, occasional paracetamol \< 2g/day, and standard dose of multivitamins).
- Consumption of alcohol, caffeinated products (coffee, tea, cola, chocolate), grapefruit fruits, or products containing grapefruit within 48 hours prior to dosing;
- Consumption of any poppy seeds (e.g., orange and poppy seed muffin, poppy seed bread) within 48 hours prior to screening and admission.
- History of drug abuse within 2 years prior to dosing; or positive alcohol/urine drug screen prior to dosing; Regular alcohol consumption within 6 months prior to dosing, i.e., on average more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol by volume or 150 mL of wine);
- Use of tobacco or nicotine products equivalent to more than 2 cigarettes a day on average within 3 months prior to dosing;
- Have special dietary requirements and are unable to comply with the diet offered and the corresponding regulations;
- Pregnant or breastfeeding female, or positive pregnancy test;
- Individuals who cannot tolerate venipuncture or who suffer from needle and blood sickness;
- Participation in another clinical study of investigational drug within 3 months prior to dosing;
- Other participants judged by the investigator to be unsuitable for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Single-arm, Open-label, Single-dose Phase I Clinical Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of rhTPO in Healthy Caucasian Participants. Approximately 22 Subjects Will be Enrolled.
This is a single-center, single-arm, open-label, single-dose phase I clinical study to evaluate pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of Recombinant Human Thrombopoietin for Injection (rhTPO) in healthy Caucasian participants. Approximately 22 healthy Caucasian participants will be enrolled for this study.
One dose level is planned in this study, and participants will receive a single abdominal subcutaneous injection at a dose of 300 U/kg after entering the study.
Participants will undergo screening, admission (baseline), administration and follow-up observation period. Participants will sign an informed consent form before any study procedures are performed. During screening, all participants will be screened for study eligibility within 28 days prior to administration. Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing (D-1). Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing. Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1~D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and ADA will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study.
Read the detailed description
This is a single-center, single-arm, open-label, single-dose phase I clinical study to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of Recombinant Human Thrombopoietin for Injection (rhTPO) in healthy Caucasian participants. Approximately 22 healthy Caucasian participants will be enrolled for this study.
One dose level is planned in this study, and participants will receive a single abdominal subcutaneous injection at a dose of 300 U/kg after entering the study.
Participants will undergo screening, admission (baseline), administration and follow-up observation period. Participants will sign an informed consent form before any study procedures are performed. During screening, all participants will be screened for study eligibility within 28 days prior to administration. Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing (D-1). Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing. Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1~D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and ADA will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study.
- Conditions
- Healthy Subjects
- Being tested
- Recombinant human thrombopoietin for injection (rhTPO)
- Keywords
- rhTPO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human thrombopoietin for injection (rhTPO)Drug
Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1~D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and anti-drug antibody (ADA) will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Caucasian volunteers | Experimental | Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1~D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and anti-drug antibody (ADA) will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study. Receives: Drug: Recombinant human thrombopoietin for injection (rhTPO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum rhTPO concentration
Pharmacokinetic index
Measured: pre-dosing and 14 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start3 Oct 2024
- Primary completion18 Nov 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3SBIO AU PTY LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arockiaa Philo Aarthy Joseph, Ph.D, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630494
- Sponsor's protocol ID
- rhTPO-101-AUS
- Status last verified
- Apr 2025
- First submitted
- 4 Oct 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Open-label, Single-dose Phase I Clinical Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of rhTPO in Healthy Caucasian Participants. Approximately 22 Subjects Will be Enrolled.
- ClinicalTrials.gov ID
- NCT06630494
- Acronym / sponsor ID
- rhTPO-101-AUS
- Conditions
- Healthy Subjects
- Keywords
- rhTPO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- 3SBIO AU PTY LTDIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 18 Nov 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 8 Oct 2024 (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 single-center, single-arm, open-label, single-dose phase I clinical study to evaluate pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of Recombinant Human Thrombopoietin for Injection (rhTPO) in healthy Caucasian participants. Approximately 22 healthy Caucasian participants will be enrolled for this study.
One dose level is planned in this study, and participants will receive a single abdominal subcutaneous injection at a dose of 300 U/kg after entering the study.
Participants will undergo screening, admission (baseline), administration and follow-up observation period. Participants will sign an informed consent form before any study procedures are performed. During screening, all participants will be screened for study eligibility within 28 days prior to administration. Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing (D-1). Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing. Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1~D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and ADA will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study.
Detailed description
This is a single-center, single-arm, open-label, single-dose phase I clinical study to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of Recombinant Human Thrombopoietin for Injection (rhTPO) in healthy Caucasian participants. Approximately 22 healthy Caucasian participants will be enrolled for this study.
One dose level is planned in this study, and participants will receive a single abdominal subcutaneous injection at a dose of 300 U/kg after entering the study.
Participants will undergo screening, admission (baseline), administration and follow-up observation period. Participants will sign an informed consent form before any study procedures are performed. During screening, all participants will be screened for study eligibility within 28 days prior to administration. Eligible participants will be admitted to the clinical study ward no later than one day prior to dosing (D-1). Participants need to fast for at least 10 hours prior to dosing and 4 hours after dosing. Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1~D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and ADA will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Caucasian volunteers | Experimental | Drug: Recombinant human thrombopoietin for injection (rhTPO)Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1~D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and anti-drug antibody (ADA) will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
Key exclusion criteria (21 listed)
- Participants are excluded from the study if any of the following criteria apply:
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 |
|---|---|---|
| Recombinant human thrombopoietin for injection (rhTPO)Single abdominal subcutaneous injection of the study drug will be given on D1. The administration and follow-up observation period will be 29 days (D1~D29). Participants may be discharged at D7 at the judgment of the investigator. PK blood samples will be collected from D-1 to D14, tolerance and safety will be observed from D1 to D29, and blood samples for PD and anti-drug antibody (ADA) will be collected from screening to D29. After completion of relevant assessments on D29, participants will be considered as having completed this study. | Drug | Healthy Caucasian volunteers |
Primary outcome
Serum rhTPO concentration
Time frame: pre-dosing and 14 days after dosing
Pharmacokinetic index
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 22 Apr 2025.
- 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.
Arockiaa Philo Aarthy Joseph, Ph.D principal investigator
Nucleus Network Pty 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 Recombinant human thrombopoietin for injection (rhTPO) in people with Healthy Subjects, run by 3SBIO AU PTY LTD 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 9 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 22 Apr 2025. 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?
Serum rhTPO concentration (time frame: pre-dosing and 14 days after 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 22 Apr 2025.