NCT05386823

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: HighField Biopharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

HF1K16 is an investigational pegylated liposome formulation of tretinoin for injection 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.

Detailed 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 HF1K16 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HF1K16	HF1K16 for Injection doses will be calculated based on subject weight measured at admission, and diluted in sterile saline (0.9% sodium chloride). Doses will be administered using an IV infusion pump over a period of approximately 60 minutes at 2.5 mL/min.
DRUG	Placebo	Placebo will be sterile saline (0.9% sodium chloride) which will be administered using an IV infusion pump over a period of approximately 60 minutes at 2.5 mL/min.

Timeline

• Start date: 2021-03-20
• Primary completion: 2021-07-30
• Completion: 2021-08-04
• First posted: 2022-05-23
• Last updated: 2024-05-23
• Results posted: 2024-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study