A Study of PD5K3 in Healthy Adult Volunteers

July 28, 2024 updated by: Chongqing Peg-Bio Biopharm Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangshu
      • Suzhou, Jiangshu, China, 215006
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Chinese healthy male or female subjects;
  2. Aged 18 to 65 years (inclusive);
  3. The body mass index (BMI) in the range 18.0~28.0 kg/m^2 (inclusive);
  4. Voluntarily participate and sign the informed consent form;
  5. Be able to complete the trial in accordance with the protocol.

Exclusion Criteria:

  1. 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;
  2. 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);
  3. Allergic constitution, including allergic to asparaginase;
  4. Used PEGylated drugs in the past;
  5. Fasting blood glucose ≥ 6.1mmol/L;
  6. Have difficulty in venous blood collection, have a history of needle phobia or blood phobia, or have a known severe bleeding tendency;
  7. Positive urine test for drug abuse;
  8. Positive breath test for alcohol;
  9. Smoke excessively (average > 5 cigarettes/day) within 3 months before screening or cannot stop using any tobacco products during the trial;
  10. 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;
  11. 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);
  12. One or more positive tests for hepatitis B virus surface antigen, hepatitis C virus antibody, syphilis specific antibody, and human immunodeficiency virus antibody;
  13. Female subjects are in lactation or have positive blood pregnancy test during the screening period or trial;
  14. Undergone surgery within 3 months before screening or plan to undergo surgery during the trial;
  15. Donated blood or lost more than 400 mL of blood within 3 months before screening (excluding menstrual bleeding);
  16. Participated in any clinical trial as a subject within 3 months before screening;
  17. Took any prescription drugs, over-the-counter drugs, health products, and any functional vitamins or Chinese herbal products within 28 days before administration;
  18. 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;
  19. The investigator believes the subject would be unsuitable for participation in this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PD5K3 group
Eight subjects will be randomized to receive a single dose of PD5K3 in a double-blind fashion at each dose level.
Drug: PD5K3
Six dose levels will be evaluated. intravenous injection
Placebo Comparator: PD5K3 Placebo group
Two subjects will be randomized to receive placebo in a double-blind fashion at each dose level.
Drug: Placebo
intravenous injection
Active Comparator: Pegaspargase group
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.
Drug: Pegaspargase
Six dose levels will be evaluated. intramuscular injection
Other Names:
  • Aiyang®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 49 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
Time Frame: up to 49 days
Pharmacokinetic parameter
up to 49 days
Maximum plasma concentration (Cmax)
Time Frame: up to 49 days
Pharmacokinetic parameter
up to 49 days
The half-life (t1/2)
Time Frame: up to 49 days
Pharmacokinetic parameter
up to 49 days
Compare the plasma asparaginase activity between the PD5K3 and pegaspargase groups
Time Frame: up to 49 days
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.
up to 49 days
Compare the plasma asparagine concentration between the PD5K3 and pegaspargase groups
Time Frame: up to 49 days
Plasma asparagine concentration as a pharmacodynamic parameter
up to 49 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chongqing Peg-Bio Biopharm Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: LiYan Miao, The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-PK-PD5K3-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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