Lymphoblastic Leukemia, AcutePhase 1NCT06527781
A Study of PD5K3 in Healthy Adult Volunteers
A Phase 1 study testing PD5K3 and Pegaspargase in people with Lymphoblastic Leukemia, Acute and Lymphoblastic Lymphoma, 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 PD5K3 in patients aged 18 to 65 years. The main questions it aims to answer are: Is PD5K3 safe in adult? Researchers will compare PD5K3 to an active comparator pegaspargase to see if PD5K3 is safe and active in human. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphoblastic Leukemia, Acute, Lymphoblastic Lymphoma
- What is being tested?
- PD5K3 and Pegaspargase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2023to 20 May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese healthy male or female subjects;
- Aged 18 to 65 years (inclusive);
- The body mass index (BMI) in the range 18.0~28.0 kg/m^2 (inclusive);
- Voluntarily participate and sign the informed consent form;
- Be able to complete the trial in accordance with the protocol.
Who cannot join
- Suffering from any diseases of the circulatory system, digestive system, urinary system, respiratory system, nervous system, endocrine system, reproductive system, etc. or any other diseases that can interfere with the test results;
- Abnormal results with clinically significance of comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, seven coagulation items, urine routine, myocardial enzymes), 12-lead electrocardiogram, chest X-ray (anteroposterior), abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney);
- Allergic constitution, including allergic to asparaginase;
- Used PEGylated drugs in the past;
- Fasting blood glucose ≥ 6.1mmol/L;
- Have difficulty in venous blood collection, have a history of needle phobia or blood phobia, or have a known severe bleeding tendency;
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- Positive urine test for drug abuse;
- Positive breath test for alcohol;
- Smoke excessively (average > 5 cigarettes/day) within 3 months before screening or cannot stop using any tobacco products during the trial;
- Drink excessively every day within 3 months before screening (male daily alcohol consumption exceeds 25g, such as 750 mL of beer, 250 mL of wine, or 75 mL of 38° liquor; female daily alcohol consumption exceeds 15g, such as 450 mL of beer, 150 mL of wine, or 50 mL of 38° liquor), or cannot abstain from alcohol during the trial;
- Drink excessive amounts of tea, coffee or caffeinated beverages every day within 3 months before screening (more than 8 cups per day, 1 cup = 250 mL);
- One or more positive tests for hepatitis B virus surface antigen, hepatitis C virus antibody, syphilis specific antibody, and human immunodeficiency virus antibody;
- Female subjects are in lactation or have positive blood pregnancy test during the screening period or trial;
- Undergone surgery within 3 months before screening or plan to undergo surgery during the trial;
- Donated blood or lost more than 400 mL of blood within 3 months before screening (excluding menstrual bleeding);
- Participated in any clinical trial as a subject within 3 months before screening;
- Took any prescription drugs, over-the-counter drugs, health products, and any functional vitamins or Chinese herbal products within 28 days before administration;
- The subject or his/her partner is unwilling to use one or more non-drug contraceptive measures (such as complete abstinence, condoms, contraceptive rings, ligation, etc.) for contraception during this trail or have a fertility plan within 6 months after the end of the study;
- 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 PD5K3 in Healthy Adult Volunteers
The main aim of this clinical trial is to assess the safety of PD5K3 in patients aged 18 to 65 years. The main questions it aims to answer are:
- Is PD5K3 safe in adult? Researchers will compare PD5K3 to an active comparator pegaspargase to see if PD5K3 is safe and active in human.
Participants will
- Receive a single dose injection of PD5K3, pegaspargase or placebo according to weight,
- Visit the clinic for assessment.
Read the detailed description
This study is a first-in-human study, which is a single-center, randomized, placebo-controlled, double-blind, dose escalation, clinical study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PD5K3 in healthy adult volunteers, compared with pegaspargase at the same dose.
- Being tested
- PD5K3, Placebo, Pegaspargase
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD5K3Drug
Six dose levels will be evaluated. intravenous injection
PlaceboDrug
intravenous injection
PegaspargaseDrug
Also called Aiyang®
Six dose levels will be evaluated. intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| PD5K3 group | Experimental | Eight subjects will be randomized to receive a single dose of PD5K3 in a double-blind fashion at each dose level. Receives: Drug: PD5K3 |
| PD5K3 Placebo group | Placebo comparator | Two subjects will be randomized to receive placebo in a double-blind fashion at each dose level. Receives: Drug: Placebo |
| Pegaspargase group | Active comparator | Four subjects will receive a single dose of pegaspargase at the each dose level, and the dose of pegaspargase is the same with PD5K3. This group is open-labelled. Receives: Drug: Pegaspargase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Adverse Events
To evaluate the adverse events as characterized by type, frequency, severity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, timing, seriousness, and relationship to study therapy after administration.
Measured: up to 49 days
Secondary outcomes (5)
The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
Pharmacokinetic parameter
Measured: up to 49 days
Maximum plasma concentration (Cmax)
Pharmacokinetic parameter
Measured: up to 49 days
The half-life (t1/2)
Pharmacokinetic parameter
Measured: up to 49 days
Compare the plasma asparaginase activity between the PD5K3 and pegaspargase groups
Plasma asparaginase activities are determined by a validated enzymatic spectrophotometric assay, and the results are reported in IU/mL. In the assay, asparaginase hydrolyzes asparagine to generate aspartic acid, which can be detected colorimetrically using a coupled enzymatic reaction.
Measured: up to 49 days
Compare the plasma asparagine concentration between the PD5K3 and pegaspargase groups
Plasma asparagine concentration as a pharmacodynamic parameter
Measured: up to 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start27 Nov 2023
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic Leukemia, AcuteStudies 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
- 28 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
- NCT06527781
- Sponsor's protocol ID
- 2023-PK-PD5K3-14
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 30 Jul 2024
- 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 30 Jul 2024. 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 PD5K3 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06527781
- Acronym / sponsor ID
- 2023-PK-PD5K3-14
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 30 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 PD5K3 in patients aged 18 to 65 years. The main questions it aims to answer are:
- Is PD5K3 safe in adult? Researchers will compare PD5K3 to an active comparator pegaspargase to see if PD5K3 is safe and active in human.
Participants will
- Receive a single dose injection of PD5K3, pegaspargase or placebo according to weight,
- Visit the clinic for assessment.
Detailed description
This study is a first-in-human study, which is a single-center, randomized, placebo-controlled, double-blind, dose escalation, clinical study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PD5K3 in healthy adult volunteers, compared with pegaspargase at the same dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PD5K3 group | Experimental | Drug: PD5K3Eight subjects will be randomized to receive a single dose of PD5K3 in a double-blind fashion at each dose level. |
| PD5K3 Placebo group | Placebo comparator | Drug: PlaceboTwo subjects will be randomized to receive placebo in a double-blind fashion at each dose level. |
| Pegaspargase group | Active comparator | Drug: PegaspargaseFour subjects will receive a single dose of pegaspargase at the each dose level, and the dose of pegaspargase is the same with PD5K3. This group is open-labelled. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese healthy male or female subjects;
- Aged 18 to 65 years (inclusive);
- The body mass index (BMI) in the range 18.0~28.0 kg/m^2 (inclusive);
- Voluntarily participate and sign the informed consent form;
- Be able to complete the trial in accordance with the protocol.
Key exclusion criteria (19 listed)
- Suffering from any diseases of the circulatory system, digestive system, urinary system, respiratory system, nervous system, endocrine system, reproductive system, etc. or any other diseases that can interfere with the test results;
- Abnormal results with clinically significance of comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, seven coagulation items, urine routine, myocardial enzymes), 12-lead electrocardiogram, chest X-ray (anteroposterior), abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney);
- Allergic constitution, including allergic to asparaginase;
- Used PEGylated drugs in the past;
- Fasting blood glucose ≥ 6.1mmol/L;
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 |
|---|---|---|
| PD5K3Six dose levels will be evaluated. intravenous injection | Drug | PD5K3 group |
| Placebointravenous injection | Drug | PD5K3 Placebo group |
| PegaspargaseAlso: Aiyang®Six dose levels will be evaluated. intramuscular injection | Drug | Pegaspargase group |
Primary outcome
Treatment-related Adverse Events
Time frame: up to 49 days
To evaluate the adverse events as characterized by type, frequency, severity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, timing, seriousness, and relationship to study therapy after administration.
5 secondary outcomes
The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
Time frame: up to 49 days
Maximum plasma concentration (Cmax)
Time frame: up to 49 days
The half-life (t1/2)
Time frame: up to 49 days
Compare the plasma asparaginase activity between the PD5K3 and pegaspargase groups
Time frame: up to 49 days
Compare the plasma asparagine concentration between the PD5K3 and pegaspargase groups
Time frame: up to 49 days
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 30 Jul 2024.
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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 PD5K3 and Pegaspargase in people with Lymphoblastic Leukemia, Acute and Lymphoblastic Lymphoma, 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 5 inclusion and 19 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 30 Jul 2024. 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 49 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 30 Jul 2024.