Chemotherapy-induced ThrombocytopeniaPhase 1NCT06523088
A Study of PN20 in Healthy Adult Volunteers
A Phase 1 study testing PN20 in people with Chemotherapy-induced Thrombocytopenia and Immune Thrombocytopenic Purpura, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 1 site in China.
Trial summary
The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years. The main questions it aims to answer are: Is PN20 safe in adult? Researchers will compare PN20 to a placebo (a look-alike substance that contains no drug) to see if PN20 is safe. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia, Immune Thrombocytopenic Purpura
- What is being tested?
- PN20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2022to 5 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects aged 18 to 50 years;
- Body mass index between 19.0-28.0 (inclusive), body mass index (BMI) = weight (kg)/height^2 (m^2);
- Female subjects of childbearing age with negative serum pregnancy test results;
- Platelet counts during the screening period and one day before enrollment are within the range of 100-300×10^9/L;
- Eligible subjects of fertility must agree to use effective contraceptive measures or abstain from sex within 6 months after receiving the investigational drug;
- Be able to understand and comply with the requirements of the protocol and expected to complete the entire trial process;
- Voluntarily participate and sign the informed consent form.
Who cannot join
- Abnormal results of vital signs examination with clinical significance determined by the investigator;
- Positive test results for HIV-Ab, HCV-Ab, HBsAg, HBeAg, or treponema pallidum antibodies;
- Abnormal results of laboratory test (blood routine, urine routine, blood biochemistry, coagulation) with clinical significance determined by the investigator;
- Abnormal electrocardiogram with clinical significance or prolonged QT/QTc interval is, such as QTcB ≥ 430ms (male), or QTcB ≥ 450ms (female) (machine reading results); family history of QT prolongation;
- Positive drug abuse test or alcohol test ≥20mg/dL;
- Abnormal results of chest CT or COVID-19 screening (nucleic acid and C-reactive protein) with clinical significance determined by the investigator;
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- Have taken any drugs (including prescription drugs, over-the-counter drugs and Chinese herbal medicines) within 4 weeks before enrollment, except for external drugs that are not absorbed by the body;
- Have used drugs known to cause significant damage to certain organs within 12 weeks before enrollment;
- Participated, enrolled and been administered in other clinical trials within 3 months before enrollment, or used this investigational drug or similar drugs;
- Received live attenuated vaccines within 28 days before administration of the trial drug and/or received inactivated vaccines within 7 days before administration, and/or plan to receive vaccines during the trial;
- Allergic constitution, or history of drug allergy, or history of allergy to the ingredients of this investigational drug;
- Have a history of major surgery or a history of blood donation ≥200 mL within 12 weeks before enrollment or who plan to donate blood during the study;
- Have a history of any serious clinical disease, including but not limited to diseases of the digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatric system (such as epilepsy, dementia, etc.), blood system, and immune system And those with a history of metabolic abnormalities, deep vein thrombosis, thrombocytopenia, thrombocythemia, platelet dysfunction, etc.;
- Smoke more than 5 cigarettes a day or have a history of alcohol abuse in the 6 months before enrollment, that is, drink more than 14 units of alcohol per week (1 unit = 12 ounces or 360mL of beer, 1.5 ounces or 45mL of hard liquor with 40% alcohol content, 5 ounces or 150mL of wine);
- Drink more than 1L of strong tea, coffee and/or caffeinated beverages every day;
- Cannot tolerate venipuncture blood collection or have a history of needle or blood fainting;
- Lactating, pregnant or planning to become pregnant or conceive in the near future;
- The investigator believes the subject would be unsuitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangshu, 215006
About this study
Official title: A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PN20 in Healthy Adult Volunteers
The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years. The main questions it aims to answer are:
- Is PN20 safe in adult? Researchers will compare PN20 to a placebo (a look-alike substance that contains no drug) to see if PN20 is safe.
Participants will
- Receive a single dose injection of PN20 or placebo according to weight,
- Stay in hospital for assessment.
Read the detailed description
This is a single center, randomized, double-blind, placebo-controlled, dose escalation phase 1 clinical study, aiming to evaluate the efficacy, safety, immunogenicity and pharmacokinetic of PN20 in healthy volunteers.
- Being tested
- PN20, Placebo
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN20Drug
Also called thrombopoietin receptor agonist
Six dose levels of PN20 will be evaluated
PlaceboDrug
Placebo of PN20
| Study group | Role | What they receive |
|---|---|---|
| PN20 group | Experimental | subcutaneous injections, a single dose Receives: Drug: PN20 |
| Placebo group | Placebo comparator | subcutaneous injections, a single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Adverse Events
Number of participants with treatment-related adverse events during the study will be collected and the percentage of AE of different grades as assessed by CTCAE v5.0 will be assessed.
Measured: up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start16 Jun 2022
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced ThrombocytopeniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523088
- Sponsor's protocol ID
- 2021-PK-PN20-32
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PN20 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06523088
- Acronym / sponsor ID
- 2021-PK-PN20-32
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 26 Jul 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.
The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years. The main questions it aims to answer are:
- Is PN20 safe in adult? Researchers will compare PN20 to a placebo (a look-alike substance that contains no drug) to see if PN20 is safe.
Participants will
- Receive a single dose injection of PN20 or placebo according to weight,
- Stay in hospital for assessment.
Detailed description
This is a single center, randomized, double-blind, placebo-controlled, dose escalation phase 1 clinical study, aiming to evaluate the efficacy, safety, immunogenicity and pharmacokinetic of PN20 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PN20 group | Experimental | Drug: PN20subcutaneous injections, a single dose |
| Placebo group | Placebo comparator | Drug: Placebosubcutaneous injections, a single dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female subjects aged 18 to 50 years;
- Body mass index between 19.0-28.0 (inclusive), body mass index (BMI) = weight (kg)/height^2 (m^2);
- Female subjects of childbearing age with negative serum pregnancy test results;
- Platelet counts during the screening period and one day before enrollment are within the range of 100-300×10^9/L;
- Eligible subjects of fertility must agree to use effective contraceptive measures or abstain from sex within 6 months after receiving the investigational drug;
Key exclusion criteria (18 listed)
- Abnormal results of vital signs examination with clinical significance determined by the investigator;
- Positive test results for HIV-Ab, HCV-Ab, HBsAg, HBeAg, or treponema pallidum antibodies;
- Abnormal results of laboratory test (blood routine, urine routine, blood biochemistry, coagulation) with clinical significance determined by the investigator;
- Abnormal electrocardiogram with clinical significance or prolonged QT/QTc interval is, such as QTcB ≥ 430ms (male), or QTcB ≥ 450ms (female) (machine reading results); family history of QT prolongation;
- Positive drug abuse test or alcohol test ≥20mg/dL;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PN20Also: thrombopoietin receptor agonistSix dose levels of PN20 will be evaluated | Drug | PN20 group |
| PlaceboPlacebo of PN20 | Drug | Placebo group |
Primary outcome
Treatment-related Adverse Events
Time frame: up to 15 days
Number of participants with treatment-related adverse events during the study will be collected and the percentage of AE of different grades as assessed by CTCAE v5.0 will be assessed.
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 13 Mar 2025.
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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.
Liyan Miao principal investigator
The First Affiliated Hospital of Soochow University
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 PN20 in people with Chemotherapy-induced Thrombocytopenia and Immune Thrombocytopenic Purpura, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 1 site in China.
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 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 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 China. 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. Some participants in this study may receive a placebo. 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?
Treatment-related Adverse Events (time frame: up to 15 days). 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 13 Mar 2025.