HealthyPhase 1NCT05386823
Evaluate the Safety, Tolerability and PK of HF1K16 in Healthy Volunteers
A Phase 1 study testing HF1K16 in people with Healthy, run by HighField Biopharmaceuticals Corporation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HF1K16
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2021to 4 Aug 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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;
- Have clinical laboratory renal (eGFR, creatinine) and liver (AST, ALT, Total bilirubin) function within normal range and other clinical laboratory results within normal range or outside normal range assessed as clinically non-significant by the Investigator at screening and admission;
- Non-smoker and has not been exposed to any products containing nicotine in the last 6 months;
- Willing and able to adhere to study restrictions and to be confined at the Clinical Research Unit
Who cannot join
- 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;
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- 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;
- A history of alcohol abuse according to medical history (≥ 2 drinks per day for male and ≥ 1 drink per day for female) within 9 months prior to screening;
- A positive screen for alcohol, drugs of abuse at screening or admission;
- An unwillingness or inability to comply with food and beverage restrictions during study participation;
- Use of over-the-counter (OTC) medication within 7 days, and/or herbal medications (including herbal teas, garlic extracts) within 7 days prior to first dose of study drug;
- Have a history of allergic reactions (either spontaneous or following drug administration) to ATRA or to any of the excipients or related compounds, including vitamin A;
- Any condition or finding that in the Investigators opinion would put the subject or study conduct at risk if the subject were to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07094
About this study
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
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.
Read the 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
- Being tested
- HF1K16, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF1K16Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 3 mg/m² HF1K16 | Experimental | Not described Receives: Drug: HF1K16 |
| 6 mg/m² HF1K16 | Experimental | Not described Receives: Drug: HF1K16 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: from Day 1 to Day 8
Secondary outcomes (3)
Peak Drug Concentration (Cmax) After Single Dose of HF1K16
To evaluate pharmacokinetic parameters of free tretinoin and liposome encapsulated tretinoin (4-oxotretinoin) in plasma after single administration of HF1K16
Measured: 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
To evaluate pharmacokinetic parameters of free tretinoin and liposome encapsulated tretinoin (4-oxotretinoin) in plasma after single administration of HF1K16
Measured: 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
- evaluate pharmacokinetic parameters of free tretinoin and liposome encapsulated tretinoin (4-oxotretinoin) in plasma after single administration of HF1K16
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start20 Mar 2021
- Primary completion30 Jul 2021
- Study completion4 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- HighField Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Tracey, MD, Principal investigator, Frontage Clinical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386823
- Sponsor's protocol ID
- HF1K16-101
- Status last verified
- May 2024
- First submitted
- 16 Mar 2022
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol and SAP
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05386823
- Acronym / sponsor ID
- HF1K16-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- HighField Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 4 Aug 2021 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Posted 23 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 mg/m² HF1K16 | Experimental | Drug: HF1K16 |
| 6 mg/m² HF1K16 | Experimental | Drug: HF1K16 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF1K16HF1K16 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 | 3 mg/m² HF1K16, 6 mg/m² HF1K16 |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
Number of Participants With Adverse Event (AE) and Severe Adverse Event (SAE)
Time frame: from Day 1 to Day 8
Safety evaluation within 8 days after first dose, including frequency of adverse event (AE) and severe adverse event (SAE)
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: from Day 1 to Day 8
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
3 secondary outcomes
Peak Drug Concentration (Cmax) After Single Dose of HF1K16
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Protocol and SAP
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Tracey, MD principal investigator
Frontage Clinical Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HF1K16 in people with Healthy, run by HighField Biopharmaceuticals Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Event (AE) and Severe Adverse Event (SAE) (time frame: from Day 1 to Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.