A Study of PD5K3 in Healthy Adult Volunteers

NCT06527781 | Completed Phase 1

• 1 other identifier: 2023-PK-PD5K3-14
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. Participants will
• Receive a single dose injection of PD5K3, pegaspargase or placebo according to weight,
• Visit the clinic for assessment.

Conditions

Lymphoblastic Leukemia, Acute; Lymphoblastic Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 49 days

Secondary Outcomes (5)

• The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)

  up to 49 days

• Maximum plasma concentration (Cmax)

  up to 49 days

• The half-life (t1/2)

  up to 49 days

• Compare the plasma asparaginase activity between the PD5K3 and pegaspargase groups

  up to 49 days

• Compare the plasma asparagine concentration between the PD5K3 and pegaspargase groups

  up to 49 days

Study Arms (3)

PD5K3 group

EXPERIMENTAL

Eight subjects will be randomized to receive a single dose of PD5K3 in a double-blind fashion at each dose level.

Drug: PD5K3

PD5K3 Placebo group

PLACEBO COMPARATOR

Two subjects will be randomized to receive placebo in a double-blind fashion at each dose level.

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.

Drug: Pegaspargase

Interventions

PD5K3 DRUG

Six dose levels will be evaluated. intravenous injection

PD5K3 group

Placebo DRUG

intravenous injection

PD5K3 Placebo group

Pegaspargase DRUG

Six dose levels will be evaluated. intramuscular injection

Also known as: Aiyang®

Pegaspargase group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Chongqing Peg-Bio Biopharm Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangshu, 215006, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

pegaspargase

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Liyan Miao

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: PD5K3 group and placebo control group are double-blinded, while the active comparator group is open-labeled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 30, 2024
• Study Start: November 27, 2023
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

CN (1)