NCT05267899

A Phase I First in Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301 in Patients With Advanced Solid Tumors

A Phase I, First in Human, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WGI-0301, a Lipid Nanoparticle Suspension of Akt-1 Antisense Oligonucleotide, in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Zhejiang Haichang Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about the effects of a study medicine, WGI-0301 to find the best dose for treating solid tumors, and to see how safe and tolerable the study drug is for patients with solid tumors. The study is also done to learn how the study drug is taken up by your body; this is called Pharmacokinetic (PK) studies and how the study drug affects the body; this is called Pharmacodynamics (PD)

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	WGI-0301	WGI-0301 is a lipid nanoparticle preparation of Archexin® for the treatment of advanced solid tumors.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-10-15
• Completion: 2024-12-31
• First posted: 2022-03-07
• Last updated: 2023-09-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study