NCT06523088

A Study of PN20 in Healthy Adult Volunteers

A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PN20 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years. The main questions it aims to answer are: * Is PN20 safe in adult? Researchers will compare PN20 to a placebo (a look-alike substance that contains no drug) to see if PN20 is safe. Participants will * Receive a single dose injection of PN20 or placebo according to weight, * Stay in hospital for assessment.

Detailed description

This is a single center, randomized, double-blind, placebo-controlled, dose escalation phase 1 clinical study, aiming to evaluate the efficacy, safety, immunogenicity and pharmacokinetic of PN20 in healthy volunteers.

Conditions

• Chemotherapy-induced Thrombocytopenia
• Immune Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	PN20	Six dose levels of PN20 will be evaluated
DRUG	Placebo	Placebo of PN20

Timeline

• Start date: 2022-06-16
• Primary completion: 2023-01-05
• Completion: 2023-01-05
• First posted: 2024-07-26
• Last updated: 2025-03-13

Locations

1 site across 1 country: China