COVID-19Phase 1NCT06860282

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

A Phase 1 study testing Remdesivir and CX2101A in people with COVID-19 and Coronavirus Pneumonia, run by Heronova Pharmaceuticals at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19, Coronavirus Pneumonia
What is being tested?: Remdesivir and CX2101A
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteChina
Study dates: 26 Dec 2022to 27 Mar 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 18Show fewer

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.
Subjects who consumed or drank pitaya, mango, pomelo, carambola, or foods or beverages prepared from them, or foods or beverages containing xanthine, caffeine, or alcohol (including chocolate, tea, coffee, cola, cocoa, etc.), or other special diets that affect the absorption, distribution, metabolism, and excretion of the drug within 72 hours before the first administration.
Subjects with special dietary requirements, lactose intolerance, or those who cannot accept the unified diet.
Subjects who, according to the investigator's judgment, are not suitable to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, 311202

Other trials in China

About this study

Official title: A Phase I, Randomized, Parallel-Controlled, Single and Multiple Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of CX2101A Enteric-Coated Tablets in Healthy Chinese Adult Subjects

Read the detailed description

Part I: Single Ascending Dose (SAD) and Food Effect (FE) Study Combined SAD and FE Study (N=42): The SAD portion is integrated with the FE study, comprising 5 dose groups: 20 mg, 80 mg, 160 mg, 300 mg, and 600 mg. The trial commences with the low-dose group and in a sequential manner. As subjects in a given dose group of CX2101A complete their safety assessments, the investigator evaluates whether the low-dose group has met the dose-escalation termination criteria. If not, the trial escalates to the next dose level.

SAD Study Enrollment: The SAD study aims to enrolls a total of 42 healthy subjects. The 20 mg dose group will enroll 4 subjects, while the 80 mg, 160 mg, and 600 mg dose groups will each enroll 8 subjects. These subjects will be randomly assigned to receive either CX2101A enteric-coated tablets or intravenous remdesivir in a 3:1 ratio.

FE Study for the 300 mg Dose Group: The 300 mg dose group will concurrently conduct a study of food effect on the pharmacokinetics (PK) of CX2101A enteric-coated tablets. This study plans to enroll 14 subjects, who will be randomly assigned to receive either CX2101A enteric-coated tablets (12 subjects) or intravenous remdesivir (2 subjects). In the first period, all 14 subjects will receive a single dose under fasting conditions according to the randomization schedule and will have blood samples collected. The 12 subjects receiving CX2101A enteric-coated tablets will undergo a 7-day washout period with a potential adjustment based on PK data from prior dose groups before proceeding to the second period, where they will receive the drug under fed conditions, complete blood sample collection, and undergo safety assessments.

Part II: Multiple Ascending Dose (MAD) Study MAD Study Design: The MAD study will include 2 dose groups, 100 mg and 300 mg. It plans to enroll 20 healthy adult subjects, with 10 subjects in each dose group. These subjects will be randomly assigned to receive either CX2101A enteric-coated tablets (8 subjects) or CX2101A placebo (2 subjects). The study will involve continuous dosing for 5 days. If the subjects in the first dose group complete their safety assessments and the investigator determines that the dose-escalation termination criteria have not been met, the study will escalate to the next dose level.

Conditions: COVID-19, Coronavirus Pneumonia
Being tested: Remdesivir, CX2101A, Placebo
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RemdesivirDrug
Intravenous remdesivir 100 mg
CX2101ADrug
CX2101A enteric-coated tablet
PlaceboDrug
CX2101A placebo enteric-coated tablet

Study groups in NCT06860282
Study group	Role	What they receive
SAD,Remdesivir	Active comparator	Participants received single dose of intravenous remdesivir. Receives: 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. Receives: Drug: CX2101A
MAD,Placebo	Placebo comparator	Participant received CX2101A placebo matching CX2101A orally once daily for 5 days. Receives: Drug: Placebo
MAD, CX2101A	Experimental	Participant received CX2101A orally once daily for 5 days. Dose levels are 100 mg and 300 mg. Receives: Drug: CX2101A
FE, CX2101A	Experimental	Participants received single dose of CX2101A 300 mg orally under fed conditions. Receives: Drug: CX2101A

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From day 1 until 5 days after treatment
Vital signs
Assessment of blood pressure
Measured: From day 1 until 5 days after treatment
Vital signs
Assessment of heart rate
Measured: From day 1 until 5 days after treatment
Vital signs
Assessment of respiratory rate
Measured: From day 1 until 5 days after treatment
Vital signs
Assessment of body temperature.
Measured: From day 1 until 5 days after treatment
Electrocardiogram (ECG)
ECG QT Interval
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Peak Concentration (Cmax): The maximum plasma concentration of the drug.
Measured: 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
Area Under the Curve from Time Zero to the Last Measurable Concentration (AUC0-t): The area under the plasma concentration-time curve from time zero to the last measurable concentration.
Measured: 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
Area Under the Curve from Time Zero Extrapolated to Infinity (AUC0-∞): The area under the plasma concentration-time curve from time zero extrapolated to infinity.
Measured: 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
Time to Reach Peak Concentration (Tmax): The time at which the peak plasma concentration is reached.
Measured: 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
Elimination Half-Life (T1/2): The time required for the plasma concentration to decrease by half.
Measured: 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
Apparent Volume of Distribution (Vz/F): The volume into which the drug appears to be distributed, corrected for bioavailability.
Measured: 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
Apparent Clearance (CL/F): The clearance of the drug from the plasma, corrected for bioavailability.
Measured: 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
Percentage of AUC Extrapolated (AUC_%Extrap): The percentage of the total AUC that is extrapolated beyond the last measurable concentration.
Measured: From time zero up to 120 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Dec 202227 Mar 2023

First posted6 Mar 2025
Study start26 Dec 2022
Primary completion27 Mar 2023
Study completion27 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06860282
Sponsor's protocol ID: SHRC-CX2101-01
Status last verified: Feb 2025
First submitted: 24 Feb 2025
Last updated: 6 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Parallel-Controlled, Single and Multiple Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of CX2101A Enteric-Coated Tablets in Healthy Chinese Adult Subjects
ClinicalTrials.gov ID: NCT06860282
Acronym / sponsor ID: SHRC-CX2101-01
Conditions: COVID-19, Coronavirus Pneumonia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Heronova PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 26 Dec 2022 (actual)
Primary completion: 27 Mar 2023 (actual)
Study completion: 27 Mar 2023 (actual)
First posted: 6 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
SAD,Remdesivir	Active comparator	Drug: RemdesivirParticipants received single dose of intravenous remdesivir.
SAD,CX2101A	Experimental	Drug: CX2101AParticipants received single dose of CX2101A orally. Dose levels are 20 mg, 80 mg, 160 mg, 300 mg and 600 mg.
MAD,Placebo	Placebo comparator	Drug: PlaceboParticipant received CX2101A placebo matching CX2101A orally once daily for 5 days.
MAD, CX2101A	Experimental	Drug: CX2101AParticipant received CX2101A orally once daily for 5 days. Dose levels are 100 mg and 300 mg.
FE, CX2101A	Experimental	Drug: CX2101AParticipants received single dose of CX2101A 300 mg orally under fed conditions.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RemdesivirIntravenous remdesivir 100 mg	Drug	SAD,Remdesivir
CX2101ACX2101A enteric-coated tablet	Drug	FE, CX2101A, MAD, CX2101A, SAD,CX2101A
PlaceboCX2101A placebo enteric-coated tablet	Drug	MAD,Placebo

Primary outcome

Rate and severity of treatment-emergent adverse events (TEAEs)
Time frame: From day 1 until 5 days after treatment
Based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Vital signs
Time frame: From day 1 until 5 days after treatment
Assessment of blood pressure
Vital signs
Time frame: From day 1 until 5 days after treatment
Assessment of heart rate
Vital signs
Time frame: From day 1 until 5 days after treatment
Assessment of respiratory rate
Vital signs
Time frame: From day 1 until 5 days after treatment
Assessment of body temperature.
Electrocardiogram (ECG)
Time frame: From day 1 until 5 days after treatment
ECG QT Interval
Physical examinations
Time frame: From day 1 until 5 days after treatment
Assessment of head, eyes, ears, nose, and throat, chest, cardiac, abdominal, extremities, neurologic, and lymph node examinations
Complete blood count test
Time frame: From day 1 until 5 days after treatment
Assessment includes Platelet Count, Hemoglobin, WBC Count (absolute), Neutrophils, Lymphocytes, Eosinophils, Monocytes, Basophils
Clinical Chemistry
Time frame: From day 1 until 5 days after treatment
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

8 secondary outcomes

PK profile of CX2101A and its metabolite CX210101,CX210108, CX210144, remdesivir and its metabolite GS-441524
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From time zero up to 120 hours post-dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Remdesivir and CX2101A in people with COVID-19 and Coronavirus Pneumonia, run by Heronova Pharmaceuticals at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate and severity of treatment-emergent adverse events (TEAEs) (time frame: From day 1 until 5 days after treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06860282.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.