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

Phase 1

Withdrawn

• Conditions: Cancer Diagnosis; Cancer - Any cancer

• Registration Number: ACTRN12622001571763
• Lead Sponsor: Earli Pty. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-20
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Be willing and able to sign the informed consent and comply with study procedures.
2. Be between the ages of 18 and 55, inclusive
3. 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.
4. Be considered healthy by the Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs
5. Have a BMI between 18-32 Kg/m2
6. Weigh more than 50 kg.
7. 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.
8. 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..
9. Be willing to abide by the study-specific restrictions on diet and exercise as described in the informed consent.
10. Not have participated in a clinical trial within the last 30 days prior to screening, or 5 half-lives, whichever is longer

Exclusion Criteria

1. A prior history of cancer.
2. A positive blood screen for human immunodeficiency virus antibodies (HIV), hepatitis B surface or core antigen (HBsAg/HBcAg), or hepatitis C antigen
3. A history of clinically significant symptomatic hypotension.
4. Abnormal systolic or diastolic BP or heart rate outside of the Linear acceptable limits at Screening or Day -1.
5. Congenital long QT syndrome or QTcF > 450 ms (males) or >470 ms (females) by history or at Screening ECG.
6. WBC, neutrophils, hemoglobin and platelet counts out of the local laboratory range of normal.
7. AST, ALT or bilirubin value > upper limit of normal (ULN) at screening. Repeat testing one time is acceptable.
8. Serum creatinine > ULN at screening.
9. A hospital admission or major surgery within 30 days prior to screening
10. A pre-planned hospital admission or surgery scheduled within 30 days after dosing.
11.. A history of prescription drug abuse or illicit drug use within 6 months prior to screening
12. A history of alcohol abuse within 6 months prior to screening as determined by the PI
13.A positive screen for alcohol or drugs of abuse including cotinine
14. 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.
15. Any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified