Part 1 and Part 3: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of AC-101

Phase 1

Active, not recruiting

• Conditions: Inflammatory Bowel Disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12623000234617
• Lead Sponsor: Accro Bioscience (Australia) Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-06
• Last Update Posted: 10 June 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Are capable of giving informed consent and complying with study procedures.
2.The age between 18 and 60 years, inclusive.
3.Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and body weight not less than 50 kg for male and 45 kg for female.
4.Female subjects have a negative serum pregnancy test result at screening and Day -1, and meet one of the following criteria:
•Using highly effective method of contraception such as implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), intrauterine hormone-releasing system (IUS) at least 1 month prior to screening and willing to continue the control for the duration of the study, and until 3 months after dosing with the study drug.
•Surgically sterile for at least 3 months prior to screening by one of the following means:
-Bilateral salpingectomy (with or without oophorectomy)
-Surgical hysterectomy
- Vasectomized partner
-Bilateral oophorectomy (with or without hysterectomy)
•Postmenopausal, defined as the following:
-Last menstrual period greater than 12 months prior to screening
-Postmenopausal status confirmed by serum follicle stimulating hormone (FSH) level of greater than or equal to 40 IU/L at screening.
5. Male subjects with female partners of child bearing potential must agree to use condoms and use highly effective method of contraception with female partner for the duration of the study and until 3 months after dosing with the study drug and must refrain from donating sperm for this same period.
6.Subjects who are exclusively in same-sex relationships (contraception is not required for female participants who are in same-sex) and subjects who abstain completely for the duration of the study and for 3 months after the last study treatment are acceptable;
7.Considered healthy by the Investigator, based on subject’s reported medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
8.Willing and able to adhere to study restrictions and to be confined at the clinical research center.

Exclusion Criteria

1.Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal (GI), hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies or food intolerances; mild and inactive hay fever is permitted), or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug; or place the subject at an unacceptable risk as a participant in this study;
2.Has had an acute illness considered clinically significant by the Investigator within 30 days prior to screening, minor colds are permitted;
3.Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range at screening and Check-in and considered clinically significant in the opinion of the Investigator. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator.
4.Taken any drug that inhibits or induces liver drug-metabolizing enzymes 30 days prior to screening; Excessive consumption of special diets (including dragon fruit, mango, grapefruit, grapefruit juice, pomelo, star fruit, Seville oranges, Seville orange marmalade or other products containing grapefruit, pomelo, star fruit or Seville oranges etc.) and/or xanthine-rich diets (including chocolate, tea, coffee, cola, etc.) or other effects that affect the absorption, distribution, metabolism, excretion and other factors of the drug 7 days prior to study drug administration;
5.Clinically significant history with sequelae of gastrointestinal tract, liver, kidney, or other diseases known to interfere drug absorption, distribution, metabolism or excretion.
6.Prolongation of QTcF (greater than 450 msec for males and greater than 470 msec for females) at screening.
7.Known current or history of malignancy.
8.Positive blood screen for hepatitis C antibody, hepatitis B surface antigen or human immunodeficiency virus (HIV) antibody.
9.A hospital admission or major surgery within 90 days prior to screening.
10.A history of prescription drug abuse, or illicit drug use within 3 months prior to screening.
11.A history of alcohol abuse according to medical history within 3 months prior to screening.
12.Has more than 5 cigarettes/week within 30 days prior to screening or intends to use any product containing nicotine during the course of the study;
13.A positive screen for alcohol, cotinine, and/or drugs of abuse at screening or Day -1.
14.An unwillingness or inability to comply with food and beverage restrictions during study participation (ie lactose intolerance; vegans and vegetarians are permitted in Part 1 and 3), and refrain from ingestion of dragon fruit, mango, grapefruit, grapefruit juice, pomelo, star fruit, Seville oranges, Seville orange marmalade or other products containing grapefruit, pomelo, star fruit or Seville oranges from 7 days prior to study drug administration to the end of the study;
15.Has had any immunizations (live vaccines) in the 4 weeks prior to screening.
16.Has used medications that affect GI motility or gastric emptying within 30 days prior to Day 1.
17.Has used any prescription or over-the-counter medication (with exception of acetaminophen at less than 2 g/day until 48 hours prior to dosing), vitamins/herbal supplements (with the exception of hormonal contraceptives) within 14 days or 5 half-lives of the drug

Study & Design

• Study Type: Interventional
• Study Design: Not specified