WithdrawnPhase 1ACTRN12622001571763

A Phase 1 Single Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EARLI-001

Sponsor

Earli Pty. Ltd.

Enrollment

10 participants

Start Date

Mar 3, 2023

Study Type

Interventional

Conditions

Cancer Diagnosis

Summary

The purpose of this study is to determine the assess the safety, tolerability, pharmacodynamics and pharmacokinetics of EARLI-001, a product developed to asses with the detection of cancer. Who is it for? You may be eligible for this study if you are a healthy adult under the age of 55. Study details Participants will receive the study drug via an infusion in the vein and be required to stay at the testing clinic for 24 hours for observation. They will then be required to attend follow-up assessments on days 3,5,7, 14 and 28. As part of this study, we will be collecting blood samples for both safety and research purposes. During the study, the estimated total blood volume to be collected will be approximately 140 mL (approximately 0.6 cups or 7 tablespoons). As a reference, a standard blood donation is 470 mL in any 12-week period. At follow-up visits, participants will also undergo physical examinations, vital sign assessments (blood pressure, pulse rate, breathing rate and temperature) and electrocardiograms for the assessment of safety. It is hoped that this research will help determine if this product is safe for use, to then be used further in future studies to determine whether this product can be used to assist cancer detection.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Inclusion Criteria13

Be willing and able to sign the informed consent and comply with study procedures.
Be between the ages of 18 and 55, inclusive
Be male or female and meet the following conditions:
Female participants must not have childbearing potential, defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (no menses for 12 months and confirmed by FSH level greater than or equal to 40 mlU/mL), or, if of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through Day 30.
Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 90 days post-dose and agree not to donate semen during this same period.
Participants who abstain from intercourse as their usual and preferred lifestyle or participants with a same-sex partner are not required to use contraception as described above. They are required to maintain abstinence from screening through Day 30.
Be considered healthy by the Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs
Have a BMI between 18-32 Kg/m2
Weigh more than 50 kg.
Be a nonsmoker, defined as not having smoked, vaped or used any form of tobacco for more than 6 months before screening. Subjects who smoke occasionally (no more than 2 cigarettes per week) are allowed to participate provided their cotinine test is negative at screening and baseline and they abstain from smoking during the study.
Be willing to stop all prescription or over-the-counter medications they are currently taking from 7 days prior to admission to Day 7 of the study..
Be willing to abide by the study-specific restrictions on diet and exercise as described in the informed consent.
Not have participated in a clinical trial within the last 30 days prior to screening, or 5 half-lives, whichever is longer

Exclusion Criteria15

A prior history of cancer.
A positive blood screen for human immunodeficiency virus antibodies (HIV), hepatitis B surface or core antigen (HBsAg/HBcAg), or hepatitis C antigen
A history of clinically significant symptomatic hypotension.
Abnormal systolic or diastolic BP or heart rate outside of the Linear acceptable limits at Screening or Day -1.
Congenital long QT syndrome or QTcF > 450 ms (males) or >470 ms (females) by history or at Screening ECG.
WBC, neutrophils, hemoglobin and platelet counts out of the local laboratory range of normal.
AST, ALT or bilirubin value > upper limit of normal (ULN) at screening. Repeat testing one time is acceptable.
Serum creatinine > ULN at screening.
A hospital admission or major surgery within 30 days prior to screening
A pre-planned hospital admission or surgery scheduled within 30 days after dosing.
A history of prescription drug abuse or illicit drug use within 6 months prior to screening
A history of alcohol abuse within 6 months prior to screening as determined by the PI
A positive screen for alcohol or drugs of abuse including cotinine
Donated more than one unit of blood or blood products during the 3 months prior to screening or receipt of a blood transfusion within one year prior to screening.
Any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

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Interventions

EARLI-001 is a recombinant DNA nanoplasmid that uses the human survivin promoter to drive cancer-activated expression of secreted embryonic alkaline phosphatase (SEAP) to act as a biomarker for the detection of cancer. EARLI-001 is given as a single intravenous dose. This is a phase 1 open-label study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of two single ascending doses of EARLI-001 in healthy participants at a single site in Australia. Up to 10 participants will receive the study drug at one of two dose levels (0.003mg/kg or 0.013mg/kg) via an intravenous infusion at a rate of ~1ml/minute. The following is how the participants will be dosed: Cohort 1 (first 5 participants): 0.003mg/kg Cohort 2 (last 5 participants): 0.013mg/kg Participants will stay confined in the clinical unit to complete safety assessments for 24 hours post-dosing and will then return to the clinical site on Days 3,5,7, 14 and 28 days post-dose for follow-up assessments. The study drug will be administered to participants by trained nurses in adherence to the strict study protocol.