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Evaluate the Safety, Tolerability and PK of HF1K16 in Healthy Volunteers

Healthy Clinical Trial

Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study Following Intravenous Administration of HF1K16 in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of HF1K16

Clinical Trial Summary

HF1K16 is an investigational pegylated liposome formulation of tretinoin for injection for the induction of remission in patients with acute promyelocytic leukemia (APL) and for the treatment of solid tumors through targeting myeloid derived suppressor cells (MDSCs). This phase 1 Trial is a Randomized, Double-Blind, Placebo-Controlled Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of HF1K16.

Clinical Trial Description

Tretinoin is a naturally occurring vitamin A metabolite that participates in many biological processes. It is not a cytolytic agent but instead induces cytodifferentiation and decreased proliferation of APL cells achieving complete remission (CR). In addition, ATRA and similar retinoids were also discovered to have significant immune-modulating activities towards Myeloid derived suppressor cells (MDSCs) that contribute greatly to cancer growth and progression. Preclinical efficacies of ATRA to induce MDSC differentiation into dendritic cells (DCs) and downregulate their inhibitory effects on cytotoxic T cell activities against cancer have been demonstrated. HF1K16 is a pegylated liposome formulation of tretinoin developed for improved PK behavior, higher therapeutic index, and more specific targeted mechanism towards MDSCs. The objectives of this study are to assess the safety and tolerability of HF1K16. The ATRA pharmacokinetic parameters will be determined with correlations to the liposome doses administered. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05386823
Study type Interventional
Source HighField Biopharmaceuticals Corporation
Contact
Status Terminated
Phase Phase 1
Start date March 27, 2021
Completion date August 8, 2021
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