NCT06527781

A Study of PD5K3 in Healthy Adult Volunteers

A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PD5K3 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Lymphoblastic Leukemia, Acute
• Lymphoblastic Lymphoma

Interventions

Type	Name	Description
DRUG	PD5K3	Six dose levels will be evaluated. intravenous injection
DRUG	Placebo	intravenous injection
DRUG	Pegaspargase	Six dose levels will be evaluated. intramuscular injection

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-05-20
• Completion: 2024-05-20
• First posted: 2024-07-30
• Last updated: 2024-07-30

Locations

1 site across 1 country: China