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

NCT05386823 | Completed Phase 1 Results FDA Drug

• 1 other identifier: HF1K16-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Event (AE) and Severe Adverse Event (SAE)

  Safety evaluation within 8 days after first dose, including frequency of adverse event (AE) and severe adverse event (SAE)

  from Day 1 to Day 8

• Number of Participants With Dose-Limiting Toxicities (DLTs)

  DLT is defined as Specify that any one grade ≥ 3 AE will halt dose escalation unless the AE is clearly and incontrovertibly due to extraneous causes; Specify that any two grade ≥ 2 AEs will halt dose escalation unless the AEs are clearly and incontrovertibly due to extraneous causes；Grade 3 asymptomatic laboratory abnormalities that resolved to ≤ grade 1 within 3 days may be excluded from the definition of DLT

  from Day 1 to Day 8

Secondary Outcomes (3)

• Peak Drug Concentration (Cmax) After Single Dose of HF1K16

  pre-infusion (within 60 minutes prior to the start of infusion) and 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, and 48 hours relative to start of infusion

• A Summary of Pharmacokinetic Parameters (AUC0-t) After Single Dose of HF1K16

  pre-infusion (within 60 minutes prior to the start of infusion) and 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, and 48 hours relative to start of infusion

• A Summary of Pharmacokinetic Parameters (Tmax) After Single Dose of HF1K16

  pre-infusion (within 60 minutes prior to the start of infusion) and 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, and 48 hours relative to start of infusion

Study Arms (3)

3 mg/m² HF1K16

EXPERIMENTAL

Drug: HF1K16

6 mg/m² HF1K16

EXPERIMENTAL

Drug: HF1K16

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HF1K16 DRUG

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.

3 mg/m² HF1K16; 6 mg/m² HF1K16

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Capable of giving informed consent and complying with study procedures;
• Between the ages of 18 and 55 years, inclusive;
• Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg;
• Female subjects must have a negative pregnancy test result at screening and at admission;
• Female subjects are:
• Surgically sterile for at least 3 months prior to screening by one of the following means:
• Bilateral tubal ligation
• Bilateral salpingectomy (with or without oophorectomy)
• Surgical hysterectomy
• Bilateral oophorectomy (with or without hysterectomy)
• Postmenopausal, defined as the following:
• Last menstrual period greater than 12 months prior to screening, and
• Postmenopausal status confirmed by serum follicle stimulating hormone (FSH) and estradiol levels at screening;
• Male subjects must agree to utilize a highly effective method of contraception (condom plus spermicide) during heterosexual intercourse from the time of clinic admission until 12 weeks following the end of study visit, and refrain from donating sperm for this same period;
• Considered healthy by the Investigator, based on subject's reported medical history, full physical examination, 12-lead ECG, and vital signs;

You may not qualify if:

• Clinically significant reported history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the Investigator;
• Known or suspected malignancy;
• Reported history of pancreatitis or gall stones;
• Reported history of unexplained syncope, symptomatic hypotension or hypoglycemia;
• Reported family history of long QTc syndrome or a QTc of \> 450 ms at screening;
• Reported history of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or intolerance;
• Poor venous access;
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at screening;
• Donated or lost \>500 mL of blood in the previous 3 months prior to screening;
• Taken an investigational drug or participated in a clinical trial within 30 days (or 5 half-lives) prior to first dose of study drug, whichever is longer;
• Taken any prescription medications within 14 days or 5 half-lives (whichever is longer) of the first dose of study drug;
• Taken any prescription or non-prescription drugs and herbal medication known to be CYP450 inducers, inhibitors, and substrates within 14 days prior to screening (See Appendix B);
• Taken daily Vitamin A supplement within 3 months prior to screening;
• Major surgery or hospitalization within 6 months prior to screening that in the Investigators opinion would put the subject or study conduct at risk;
• A history of prescription drug abuse, or illicit drug use within 9 months prior to screening;

Sponsors & Collaborators

• HighField Biopharmaceuticals Corporation: lead

Study Sites (1)

Frontage Clinical Services, Inc.

Secaucus, New Jersey, 07094, United States

Location

Results Point of Contact

• Title: Dr. Yuhong Xu
• Organization: HighField BioPharmaceuticals Corporation

yhxu@hf-biopharm.com

+86-571-86961869

Study Officials

• Gregory Tracey, MD

  Frontage Clinical Services, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: May 23, 2022
• Study Start: March 20, 2021
• Primary Completion: July 30, 2021
• Study Completion: August 4, 2021
• Last Updated: May 23, 2024
• Results First Posted: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: six month after completion
• Access Criteria: public

Locations

US (1)