A Trial of CRB4101 in Healthy Subjects

NCT05641181 | Unknown Phase 1 DMC

• 1 other identifier: HZhao
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Incidence and severity of adverse events

  Start of Treatment to end of study (approximately 20 days)

Secondary Outcomes (19)

• Pharmacokinetics-Tmax

  Up to 3 days

• Pharmacokinetics-Cmax

  Up to 3 days

• Pharmacokinetics-AUC0- 24h

  Up to 3 days

• Pharmacokinetics-AUC0-t

  Up to 3 days

• Pharmacokinetics-AUC0-∞

  Up to 4 days

Study Arms (7)

CRB4101 100mg dose group

EXPERIMENTAL

Participants will receive a single oral dose of 100mg of CRB4101

Drug: CRB4101

CRB4101 200mg dose group

EXPERIMENTAL

Participants will receive a single oral dose of 200mg of CRB4101

Drug: CRB4101

CRB4101 400mg dose group

EXPERIMENTAL

Participants will receive a single oral dose of400mg of CRB4101

Drug: CRB4101

CRB4101 800mg dose group

EXPERIMENTAL

Participants will receive a single oral dose of 800mg of CRB4101

Drug: CRB4101

CRB4101 1200mg dose group

EXPERIMENTAL

Participants will receive a single oral dose of 1200mg of CRB4101

Drug: CRB4101

CRB4101 1600mg dose group

EXPERIMENTAL

Participants will receive a single oral dose of 1600mg of CRB4101

Drug: CRB4101

placebo group

PLACEBO COMPARATOR

Subjects will receive a placebo

Drug: Placebo

Interventions

CRB4101 DRUG

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 In each dose group, 8 participants will be enrolled to receive the drug, including 6 receiving CRB4101 tablets and 2 receiving placebo.

Also known as: Drug intervention

CRB4101 100mg dose group; CRB4101 1200mg dose group; CRB4101 1600mg dose group; CRB4101 200mg dose group; CRB4101 400mg dose group; CRB4101 800mg dose group

Placebo DRUG

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 In each dose group, 8 participants will be enrolled to receive the drug, including 6 receiving CRB4101 tablets and 2 receiving placebo.

Also known as: Placebo intervention

placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female participants aged between 18 and 50 years (including 18 and 50 years) (the ratio of male/female participants to all is required to be no less than 1/3 in the groups with the dose of 200mg, 400mg and 800mg);
• Male weight in the range of 50 kg(inclusive) to 90kg, female weight in the range of 45 kg(inclusive) to 90 kg, body mass index (BMI= weight/height square (kg/㎡)) :19.0≤BMI \< 28.0;
• participant who is able to communicate well with the investigator and is willing and able to comply with all planned visits, laboratory examinations, and other study procedures.
• Have fully understood this study, voluntarily participated in the experiment, and have signed written informed consent form.

You may not qualify if:

• Pregnant, lactating women, or female participants of childbearing potential who have not used contraception for at least 30 days before drug administration; Male participants who are unwilling to use contraception (or could not guarantee not to donate sperm) and female participants of childbearing potential who are unwilling to use contraception during enrollment in the trial and for 90 days after dosing;
• Suspected or definitely confirmed (inquiry) allergy to the study drug or any component in the study drug, or allergic constitution;
• participants with diseases or previous diseases (including but not limited to cardiac/cardio-cerebrovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, malignant, hematological, immune, infectious, neurological or psychiatric diseases), surgical history or any other conditions judged by the investigator to affect the absorption, distribution, metabolism and excretion of drugs or to reduce compliance ;
• Have a personal or family history of bleeding diseases or coagulopathy, or have long-term or unexplained abnormal bleeding, such as frequent epistaxis (nosebleeds), gum bleeding, or have a high risk of bleeding such as hemorrhoids, gastrointestinal ulcers, or often have unexplained bruises/ecchymosis; participants with definite history of hemoptysis, hematemesis, melena or hematuria; Or women who are expected to be menstruating at the time of administration;
• History of cerebral hemorrhage (including congenital cerebral vascular malformations such as cerebral arteriovenous malformations or cavernous hemangiomas), stroke, and cerebrovascular accident (CVA)
• Have had risk factors for torsade de pointes, or have had a first-degree relative (i.e., biological parent, sibling, or child) family history of short QT syndrome, long QT syndrome, unexplained sudden death, drowning, or sudden infant death in young adulthood (less than or equal to 40 years of age);
• Abnormal and clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia as judged by the investigator;
• participants received anticoagulant or antiplatelet therapy within 1 month before screening; Or with adverse reactions of anticoagulant or antiplatelet drugs;
• participants with severe head trauma or major head surgery within 2 years before screening;
• Underwent major surgery within 3 months before screening or any surgery within 1 month before screening or plan to undergo surgery within 2 weeks after the end of the study;
• Individuals who has donated blood within 1 month prior to screening, or donated ≥400 mL of blood within 3 months prior to screening, or received blood or blood component transfusion within 8 weeks prior to screening and before dosing;
• Taking any prescription drugs, over-the-counter drugs or herbal medicines within 2 weeks before taking the study drug, or within 5 half-lives of the drug at the time of screening;
• Regular alcohol use in the 3 months before screening (14 units per week: 1 unit = 285 mL of beer; Or liquor 25 mL; Or wine 125 mL), or with abnormal results of alcohol breath test before enrollment;
• Smoking (≥5 cigarettes per day) or using smoking cessation products or nicotine-containing products within 2 weeks before taking the study drug; Or unable to stop using any tobacco-based products after enrollment throughout the trial;
• participants with glucose intolerance or rare genetic diseases - galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;

Sponsors & Collaborators

• China Resources Biopharmaceutical Co., Ltd: lead
• Peking University Third Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 000000, China

RECRUITING

Central Study Contacts

HaiYan Li, professor

CONTACT

010-82266226; haiyanli1027@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 100mg, 200 mg, 400 mg, 800 mg, 1200 mg, 1600 mg

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 7, 2022
• Study Start: November 16, 2022
• Primary Completion: April 5, 2023
• Study Completion: June 21, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)