A Phase I Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses of RS1805 Tablets in Healthy Adult Subjects

Phase 1

Completed

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

• Registration Number: ACTRN12620000910909
• Lead Sponsor: Atridia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-14
• Study Completion: 2021-05-19
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Healthy adult subjects, male or female, 18 to 55 years of age (inclusive) at the time of informed consent.
Subject with body mass index (BMI equal to weight/height squared) between 18 and 32 kg/m2 (inclusive), male equals to 50 kg and female equals to 48 kg.

Good overall health at screening based on the results of medical history, physical examination, vital signs, laboratory tests, 12-lead ECG, and chest radiography at screening.

All women of childbearing potential and all men with female partners of childbearing potential must use effective contraception method throughout the study, and for 1 month after the last dose.

Subjects understand and comply with the study requirements, voluntarily participate in this trial, and sign the written informed consent form

Exclusion Criteria

Suspected allergy to the study drug or any component of the study drug, or allergic constitution

History of malignant tumor; with the exception of subjects with non-melanoma skin cancer that was cured > 2 years ago and cervical intraepithelial neoplasia that was cured > 5 years ago.

Subjects have any surgical operation within 3 months prior to screening, or subjects have not recovered from prior surgery as judged by investigators, or plan to receive the operation during the study and within 1 month after completing all study visits

History of clinical major heart disease, liver disease, nerve disease, respiratory disease, blood disease, digestive disease, immune disease, kidney disease or mental disease, which is considered by the investigator to confuse the study results or affect absorption, distribution, metabolism and excretion of drug or place the subjects at improper risks

Any disease that affects drug absorption, distribution, metabolism and excretion as judged by the investigator (e.g., gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, etc.);

Active tuberculosis indicated by clinical symptoms, signs, laboratory tests or chest X-ray; latent tuberculosis indicated by T-spot or Quanti-FERON TB test

Investigator-judged clinically significant infections within 1 month prior to screening, including acute and chronic infections such as abscess, furuncle, carbuncle and other local infections, respiratory tract infections, urinary and reproductive infections, systemic infections, etc. Minor skin or respiratory infections that have completely resolved even within 1 month are acceptable at the discretion of the investigator

Participation in any clinical trial of drug or medical device within 3 months prior to screening (or 5 half-lives of drug, whichever is longer);

Any acute disease with clinical significance as judged by the investigator within 1 month prior to screening

Subjects who cannot discontinue CYP3A inducers or CYP3A inhibitors 14 days prior to baseline visit and during the study

Subjects who have received any live vaccine within 1 month prior to screening or need to receive live vaccine during the study (including 30 days after the last dose of study drug);

Use of prescription drug within 14 days prior to baseline and during the study, with the exception of hormonal contraception, topical medications at the discretion of the investigator, brief use of medications for non-exclusionary conditions that are not expected to interfere with safety or data quality at the discretion of the Principal Investigator and Sponsor

Use of over-the-counter drugs, including natural health products (e.g., food supplements and herbal supplements) within 14 days prior to baseline, with the exception of occasional use of paracetamol (up to 2 g daily), ibuprofen, or regular doses of vitamins

QTc greater than 450 ms or other significant ECG abnormalities with clinically significance as judged by the investigator.

White blood cell count, neutrophil count, lymphocyte count or hemoglobin in hematology exceed the normal reference range and is judged as clinically significant by the investigator.

Alanine aminotransferase (ALT) > 1.5 times the upper limit of normal (ULN) and/or aspartate aminotransferase (AST) > 1.5 times ULN and/or bilirubin > 1.5 times ULN;

Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m² calculated by the Modification of Diet in Renal Disease (M

Study & Design

• Study Type: Interventional
• Study Design: Not specified