A Study of CX2101A Enteric-Coated Tablets in Healthy Chinese Adult Subjects

NCT06860282 | Completed Phase 1

• 1 other identifier: SHRC-CX2101-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study is divided into two parts, including Part I: a randomized, open-label, positive drug-controlled, single ascending dose (SAD) study, a food effect (FE) study, and Part II: a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) study.

Conditions

COVID-19; Coronavirus Pneumonia

Outcome Measures

Primary Outcomes (9)

• Rate and severity of treatment-emergent adverse events (TEAEs)

  Based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0

  From day 1 until 5 days after treatment

• Vital signs

  Assessment of blood pressure

  From day 1 until 5 days after treatment

• Vital signs

  Assessment of heart rate

  From day 1 until 5 days after treatment

• Vital signs

  Assessment of respiratory rate

  From day 1 until 5 days after treatment

• Vital signs

  Assessment of body temperature.

  From day 1 until 5 days after treatment

• Electrocardiogram (ECG)

  ECG QT Interval

  From day 1 until 5 days after treatment

• Physical examinations

  Assessment of head, eyes, ears, nose, and throat, chest, cardiac, abdominal, extremities, neurologic, and lymph node examinations

  From day 1 until 5 days after treatment

• Complete blood count test

  Assessment includes Platelet Count, Hemoglobin, WBC Count (absolute), Neutrophils, Lymphocytes, Eosinophils, Monocytes, Basophils

  From day 1 until 5 days after treatment

• Clinical Chemistry

  Assessment includes BUN, Creatinine, Glucose (fasting), Sodium, Total Protein, Magnesium , Potassium, Chloride, Total CO2, Calcium, Albumin, AST (SGOT), ALT (SGPT), Phosphorous, Alkaline phosphatase, Total and direct bilirubin

  From day 1 until 5 days after treatment

Secondary Outcomes (8)

• PK profile of CX2101A and its metabolite CX210101,CX210108, CX210144, remdesivir and its metabolite GS-441524

  From time zero up to 120 hours post-dose

• PK profile of CX2101A and its metabolite CX210101,CX210108, CX210144, remdesivir and its metabolite GS-441524

  From time zero up to 120 hours post-dose

• PK profile of CX2101A and its metabolite CX210101,CX210108, CX210144, remdesivir and its metabolite GS-441524

  From time zero up to 120 hours post-dose

• PK profile of CX2101A and its metabolite CX210101,CX210108, CX210144, remdesivir and its metabolite GS-441524

  From time zero up to 120 hours post-dose

• PK profile of CX2101A and its metabolite CX210101,CX210108, CX210144, remdesivir and its metabolite GS-441524

  From time zero up to 120 hours post-dose

Study Arms (5)

SAD,Remdesivir

ACTIVE COMPARATOR

Participants received single dose of intravenous remdesivir.

Drug: Remdesivir

SAD,CX2101A

EXPERIMENTAL

Participants received single dose of CX2101A orally. Dose levels are 20 mg, 80 mg, 160 mg, 300 mg and 600 mg.

Drug: CX2101A

MAD,Placebo

PLACEBO COMPARATOR

Participant received CX2101A placebo matching CX2101A orally once daily for 5 days.

Drug: Placebo

MAD, CX2101A

EXPERIMENTAL

Participant received CX2101A orally once daily for 5 days. Dose levels are 100 mg and 300 mg.

Drug: CX2101A

FE, CX2101A

EXPERIMENTAL

Participants received single dose of CX2101A 300 mg orally under fed conditions.

Drug: CX2101A

Interventions

Remdesivir DRUG

Intravenous remdesivir 100 mg

SAD,Remdesivir

CX2101A DRUG

CX2101A enteric-coated tablet

FE, CX2101A; MAD, CX2101A; SAD,CX2101A

Placebo DRUG

CX2101A placebo enteric-coated tablet

MAD,Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers aged between 18 and 55 years old (including 18 and 55 years old), regardless of gender.
• For male volunteers, the body weight should be ≥ 50.0 kg, and for female volunteers, the body weight should be ≥ 45.0 kg. The body mass index (BMI) = body weight (kg) / height² (m²), and it should be within the range of 19.0 to 28.0 kg/m². Women of childbearing potential (WOCBP) or the female partners of male subjects should be willing to have no plans for childbearing from 2 weeks before the screening until 3 months after the last administration of the investigational medicinal product, and voluntarily adopt effective contraceptive measures (including one or more non-pharmacological contraceptive measures), and have no plans for sperm donation or egg donation.
• No history of major diseases, and the results of physical examination, vital signs, 12-lead electrocardiogram, chest X-ray examination and laboratory tests during the screening period are normal, or although slightly beyond the normal reference value range, they are judged by the investigator to have no clinical significance.
• The subject should be able to maintain good communication with the investigator, comply with various requirements of the clinical trial, and voluntarily sign the informed consent form.

You may not qualify if:

• Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded, including but not limited to those in the nervous/mental system, respiratory system, cardiovascular and cerebrovascular system, digestive system (any history of gastrointestinal diseases that affect drug absorption), hematological and lymphatic system, urinary system, endocrine system, and immune system.
• Acute diseases that occurred from the screening stage to before the administration of the investigational medicinal product and are judged by the investigator to possibly affect the research results.
• Subjects who cannot tolerate intravenous puncture or those with a history of syncope judged by the investigator to be of clinical significance.
• Subjects with difficulty in swallowing.
• Subjects who are judged by the investigator to possibly or definitely have an allergic reaction to the investigational drug, remdesivir (including similar drugs), or any of its excipients; or subjects with an allergic constitution judged by the investigator to be of clinical significance (a history of severe allergies to multiple drugs and foods) or a history of allergic diseases.
• Subjects who have undergone surgery before screening and are judged by the investigator to possibly affect the absorption, distribution, metabolism, and excretion of the drug, or subjects with severe surgical sequelae, or subjects who plan to undergo surgery during the study period.
• Subjects who donated blood or had massive blood loss (≥ 400 mL), donated ≥ 2 units of component blood, or received a blood transfusion within 3 months before the first administration of the trial, or those who plan to donate blood during the trial.
• Subjects who received any investigational drug in a clinical study or participated in any interventional clinical study within 3 months before the first administration of the trial.
• Subjects who smoked an average of more than 5 cigarettes per day within 3 months before the first administration of the trial, or those who cannot stop using any tobacco products during the trial.
• Subjects who consumed an average of more than 14 units of alcohol per week within 3 months before the first administration of the trial (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine), or those who cannot stop using any alcohol-containing products during the trial, or those with a positive alcohol breath test before the administration of the trial.
• Subjects who consumed an excessive amount of tea, coffee, and/or caffeine-containing beverages on average per day (more than 8 cups on average, 1 cup ≈ 250 mL) within 3 months before the first administration of the trial, or those who cannot stop consuming tea, coffee, and/or caffeine-containing beverages during the trial.
• Subjects who used any prescription drugs, over-the-counter drugs, traditional Chinese patent medicines, Chinese herbal medicines, vitamins, or health foods within 28 days before screening or within 5 drug half-lives (whichever is longer).
• Female subjects who are pregnant or breastfeeding, or those with a positive blood/urine pregnancy test (only for WOCBP) at any time before the first administration.
• Positive results or results exceeding the upper limit of the reference range for the four hemodialysis tests: hepatitis B surface antigen (HBsAg), quantitative hepatitis C (HCV) antibody, quantitative human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody.
• Subjects with a positive urine drug screening (morphine, tetrahydrocannabinolic acid, methamphetamine, methylenedioxymethamphetamine, ketamine) or those with a history of drug abuse or drug use within the past 5 years before the trial.

Sponsors & Collaborators

• Heronova Pharmaceuticals: lead

Study Sites (1)

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, 311202, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

remdesivir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Part 1 is open label, Part 2 is double-blinded (participant and investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 6, 2025
• Study Start: December 26, 2022
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)