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

NCT05386823 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-05-23

Study results available
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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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • HighField Biopharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Gregory Tracey, MD · Frontage Clinical Services, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-20
Primary Completion
2021-07-30
Completion
2021-08-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386823 on ClinicalTrials.gov