ABP-745 Safety Study in Healthy Volunteers

(ABP-745 Trial)

Overseen By Ullrich Schwertschlag, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Must not be taking: All medications

Disqualifiers: Gastrointestinal, Liver, Kidney, others

Compensation: Varies

Number of Visits: Unknown

126 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will test a new drug called ABP-745 in healthy volunteers. Researchers want to see if the drug is safe and how it moves through the body. They will give different doses to understand its effects better.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications (both prescription and nonprescription) at least 14 days before the first dose of the study drug, except for oral contraceptives or topical ointments, which may be allowed.

How does the drug ABP-745 differ from other treatments for its condition?

ABP-745 is unique because it is a piperine analog, which means it is related to a compound found in black pepper that can modulate GABAA receptors in the brain. This drug's ability to cross the blood-brain barrier effectively, as shown in various models, may offer a novel approach compared to existing treatments that might not target these receptors or penetrate the brain as efficiently. ^{1 2 3 4 5}

Eligibility Criteria

Healthy volunteers aged 18-55 with a BMI of 18-30 kg/m2 and weight over 50 kg for males and 45 kg for females. Participants must not be on medication, have no history of significant health issues that affect drug processing, no drug abuse in the past two years, non-smokers or able to abstain during the study, and women must use contraception.

Inclusion Criteria

Body mass index (BMI) range within 18 ~ 30 kg/m2, and body weight of ≥ 50.0 kg for male and ≥ 45.0 kg for female

I am generally healthy according to recent medical exams and tests.

I will use effective birth control from screening until 90 days after my last dose.

Exclusion Criteria

Known history of drug abuse within 2 years before the screening; or positive drug abuse test at screening

Blood donation or blood loss of more than 400 mL within 3 months before the screening

Positive screening test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Dose Treatment

Participants receive a single oral dose of ABP-745 or placebo to evaluate safety, tolerability, and pharmacokinetics

1 week

Multiple Dose Treatment

Participants receive multiple oral doses of ABP-745 or placebo to evaluate safety, tolerability, and pharmacokinetics

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ABP-745

Trial Overview The trial is testing ABP-745's safety and how it's processed by the body when taken orally. It involves giving healthy people either ABP-745 or a placebo without them knowing which one they're getting. The test will happen twice: once as a single dose (Part 1) and again as multiple doses (Part 2).

Participant Groups

Group I: ABP-745 Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

7

Recruited

880+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

In vitro blood-brain barrier permeability predictions for GABAA receptor modulating piperine analogs. [2022]

2. Singapore pubmed.ncbi.nlm.nih.gov

Development of Human in vitro Brain-blood Barrier Model from Induced Pluripotent Stem Cell-derived Endothelial Cells to Predict the in vivo Permeability of Drugs. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Tuning the predictive capacity of the PAMPA-BBB model. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Confounding parameters in preclinical assessment of blood-brain barrier permeation: an overview with emphasis on species differences and effect of disease states. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

IVIVC Assessment of Two Mouse Brain Endothelial Cell Models for Drug Screening. [2021]