MedTrace Logo

A Study of PD5K3 in Healthy Adult Volunteers

NCT06527781 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-07-30

No results posted yet for this study

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

Interventions

DRUG

PD5K3

Six dose levels will be evaluated. intravenous injection

DRUG

Placebo

intravenous injection

DRUG

Pegaspargase

Six dose levels will be evaluated. intramuscular injection

Sponsors & Collaborators

  • Chongqing Peg-Bio Biopharm Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Liyan Miao · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2024-05-20
Completion
2024-05-20

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06527781 on ClinicalTrials.gov