A Trial of CRB4101 in Healthy Subjects

Healthy Adult Subjects Clinical Trial

Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose CRB4101 Tablets in Healthy Adult Subjects

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is toevaluate the safety and tolerability of a single dose of CRB4101 tablets in healthy adults . The main questions it aims to answer are:

• [question 1]The pharmacokinetics (PK) and pharmacodynamic dynamics (PD) characteristics of CRB4101 tablets were evaluated in healthy adults after a single administration.

• [question 2]Exploratory analysis of the relationship between serum concentrations of CRB4101 (and its major metabolites, if necessary) and QTc interphase.

• [question 3]Exploratory analysis of the metabolic and excretory characteristics of CRB4101 after a single administration (if necessary)

• [question 4]Exploratory analysis of pharmacokinetic characteristics of major metabolites of CRB4101 (if necessary)

• [question 5]The influence of pharmacogenomics on pharmacokinetic characteristics (if necessary).

After the participants who signed the informed consent have been screened by the inclusion criteria, those who meet the inclusion criteria and those who do not meet the exclusion criteria will receive the following 6 dose groups in order from low to high:

100mg, 200 mg, 400 mg, 800 mg, 1200 mg, 1600 mg

Clinical Trial Description

The subjects who signed the informed consent form were screened by the inclusion and exclusion criteria. The subjects who met the inclusion criteria and did not meet the exclusion criteria were treated with 100 mg, 200mg, 400mg, 800 mg, 1200 mg and 1600 mg in order from low to high. In each dose group, 8 subjects will be enrolled to receive CRB4101 tablets (6 subjects) and placebo (2 subjects). In order to ensure the safety of the subjects, the sentinel method was used to enroll the subjects. Two subjects were enrolled in each dose group (1 patient received CRB4101 and 1 patient received placebo), and the safety of the drugs was evaluated at least 24 hours after administration. The remaining 6 subjects (5 to receive CRB4101 tablets and 1 to receive placebo) could be enrolled if the investigator assessed that the subjects had tolerable safety. Therefore, a total of 48 subjects were planned to be recruited for single-dose safety, tolerability, PK, and PD studies. Subjects were admitted to the clinical trial facility 1 day before administration (D-1), fasted for at least 10 h before administration, and received a single oral dose of CRB4101 tablets or placebo on the day of administration (D1). Subjects will be hospitalized for laboratory tests, vital signs, adverse events, safety and tolerability evaluation, and PK and PD samples of CRB4101 tablets will be collected. Subjects will leave the clinical trial facility after completing the safety assessment on the 4th day after administration (D4), return to the clinical trial facility 10 days after departure (D14±1), and leave the clinical trial facility after completing the last safety check (safety follow-up).

The dose was increased from low to high, and each subject could only receive one dose. "When safety data are available for all patients in a dose arm after day 14, the investigator and the sponsor will jointly assess safety, tolerability, and available PK/PD results at that dose level to determine whether to proceed to the next dose arm." If the criteria for dose escalation were met, escalation to the next dose was performed. If the criteria for discontinuation of dose escalation were met, exploration could continue at the reduced dose level after joint review and confirmation by the investigator and sponsor. If after the maximum climbing dose (1600 mg) was reached, the review of human safety data did not meet the stopping criteria, and the investigator and the sponsor jointly decided that further climbing was necessary, the Ethics committee needed to apply for an increase again. If criteria for dose escalation were observed to be met in a given group, the plan would be discontinued. At this point, the investigator and the sponsor could discuss together whether to continue the study with a dose reduction based on available safety, tolerability, PK, and PD data. Option to continue the study at 1000 mg). ;

Related Conditions & MeSH terms

• Healthy Adult Subjects

• NCT number: NCT05641181
• Study type: Interventional
• Source: China Resources Biopharmaceutical Co., Ltd
• Contact: HaiYan Li, professor
• Phone: 010-82266226
• Email: haiyanli1027@hotmail.com
• Status: Recruiting
• Phase: Phase 1
• Start date: November 16, 2022
• Completion date: June 21, 2023