Healthy SubjectsPhase 1UP-818-CCNCT07355621
UP-818-CC Injection in Healthy Chinese Subjects
A Phase 1 study testing UP-818-CC injection in people with Healthy Subjects, run by EnliTISA (Shanghai) Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The objectives of this study are to evaluate the safety, tolerability and pharmacokinetic characteristics in healthy Chinese volunteers after single and multiple dose of intravenous infusion of UP-818-CC. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- UP-818-CC injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2022to 20 Feb 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) in the range of 19 to 26, including boundary values, BMI = weight (kg) / height (m) 2;
- The medical history, physical examination, laboratory items and tests related to the trial are all normal or abnormal and have no clinical significance, and the clinical research doctor judges that they are qualified;
- During the trial and within 3 months after the trial, the subjects or their spouses voluntarily took effective contraceptive measures, such as abstinence, condoms, the use of intrauterine devices, double-barrier methods (such as condoms and contraceptive diaphragms), etc., female subjects enter the trial after confirming the menstrual period; male subjects have no sperm donation plan;
- Be able to communicate well with researchers, fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign written informed consent.
Who cannot join
- Those who are allergic to any active ingredient of the investigational drug or any excipient or excipient;
- Allergies (including bronchial asthma or asthmatic bronchitis, allergic rhinitis and other multiple drug or food allergies, etc.) or the total IgE results of the screening period showed allergies;
- Those with past or current diseases that the investigator considers ineligible to enroll, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, genitourinary system, metabolism and bone, or those with a history of allergic diseases or malignant tumors;
- Past or current chronic obstructive pulmonary disease, active pulmonary tuberculosis (including but not limited to increased erythrocyte sedimentation rate or a positive T-cell spot test for tuberculosis infection in the screening period or abnormal and clinically significant chest CT examination in the screening period, judged by the investigator afterwards, only those with calcifications and no clinically significant symptoms on lung imaging examinations can be enrolled) and other respiratory diseases;
- Patients with acute infection within 2 weeks before screening;
- Difficulty in venous blood collection, or those with a history of needle dizziness or haemorrhage;
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- Frequent excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup = 200 ml) in the 3 months prior to screening or ingestion of any food or drink containing caffeine, alcohol, xanthine or grapefruit within 48 hours prior to randomization;
- History of binge drinking or frequent alcohol consumption within 6 months prior to the trial (more than 14 units of alcohol per week, 1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) or alcohol breath test the day before dosing is positive (breath alcohol content > 0.0 mg/100 mL), or those who cannot abstain from alcohol during the test;
- Those who have participated in any drug clinical trial and have taken the investigational drug within 3 months before screening;
- Donate blood or lose ≥400 mL of blood within 3 months before screening (except for female menstrual blood loss), or plan to donate blood or blood components during the study or within 3 months after the end of the study;
- Persons with a history of drug abuse/dependence or drug history within 1 year before screening, or those with positive drug abuse screening (screening items may include: morphine, THC, methamphetamine, DMD fetamine, ketamine and cocaine);
- Those who smoked more than 5 cigarettes per day within 3 months before screening and those who could not smoke during the whole trial period;
- Have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or health products within 14 days before screening;
- Post-vaccination within 4 weeks prior to the first dose of investigational drug or planned within 4 weeks after the last dose is discontinued, live vaccines including but not limited to: measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG Bacillus, typhoid vaccine, live COVID-19 vaccine, etc.;
- During the screening period, the QTcF interval >450 milliseconds (msec) or the abnormal and clinically significant results of the 12-lead ECG;
- During the screening period, the investigators determined that the vital signs were abnormal: systolic blood pressure <90 mmHg or ≥140 mmHg, diastolic blood pressure <50 mmHg or ≥90 mmHg, or the body temperature, heart rate, pulse, respiration, blood oxygen saturation and other indicators exceeded the center normal value range and the investigator judges that the abnormality has clinical significance;
- During the screening period, estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2 by MDRD equation (Appendix 3);
- Those who are positive for one or more of hepatitis B surface antigen, hepatitis C virus (HCV) antibody, syphilis antibody (TPPA) or human immunodeficiency virus (HIV) antibody;
- Those who cannot communicate or cooperate with medical staff due to neurological, mental illness or language barriers;
- The investigator believes that the subjects are not suitable to participate in the trial, or the subjects cannot participate in the trial due to their own reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of UP-818-CC Injection in Healthy Chinese Subjects After Single-dose and Multiple-dose Intravenous Infusion
The objectives of this study are to evaluate the safety, tolerability and pharmacokinetic characteristics in healthy Chinese volunteers after single and multiple dose of intravenous infusion of UP-818-CC.
This study is divided into two parts, single ascending dose part (SAD) and multiple ascending dose part (MAD), both conducted in healthy subjects, using a randomized, double-blind, placebo-controlled, dose-escalating design.
Read more
The SAD part is planned to be carried out in 6 dose groups. A total of about 43 healthy adult subjects are planned to be included. All subjects will receive a single dose on the first day (D1).
According to the obtained PK and safety information of the SAD, three appropriate dose groups are selected in MAD. A total of about 30 healthy adult subjects, both male and female, will be included. All subjects will receive multiple doses from D1 to D7, once daily.
- Conditions
- Healthy Subjects
- Being tested
- UP-818-CC injection, Placebo
- Keywords
- UP-818-CC injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UP-818-CC injectionDrug
UP-818-CC injection
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| UP-818-CC group | Experimental | single or multiple intravenous UP-818-CC injection Receives: Drug: UP-818-CC injection |
| placebo group | Placebo comparator | single or multiple intravenous placebo injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events as coded by MedDRA and assessed by CTCAE v5.0
Number of Participants with Treatment-Related Adverse Events following administration of UP-818-CC injection.
Measured: From baseline to Day4 in single dose groups, from baseline to Day 10 in multi-dose groups.
Secondary outcomes (8)
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (maximum observed drug concentration)
Blood samples will be collected before and up to 72 hours after the administration to test the concentration of UP-818-CC and get maximum observed drug concentration.
Measured: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (area under the curve)
Blood samples will be collected before and up to 72 hours after the administration to get area under the curve .
Measured: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (time to reach maximum drug concentration)
Blood samples will be collected before and up to 72 hours after the administration to get time to reach maximum drug concentration.
Measured: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (area under the drug-time curve at 0 to infinity time)
Blood samples will be collected before and up to 72 hours after the administration to get area under the drug-time curve at 0 to infinity time.
Measured: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (elimination half-life)
Blood samples will be collected before and up to 72 hours after the administration to get elimination half-life.
Measured: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (clearance rate)
Blood samples will be collected before and up to 72 hours after the administration to get the clearance rate.
Measured: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (apparent volume of distribution)
Blood samples will be collected before and up to 72 hours after the administration to get apparent volume of distribution.
Measured: Up to 72 hours
Urine pharmacokinetic parameters of UP-818-CC following a single-dose and multiple-doses of UP-818-CC injection (the drug concentration).
For PK analysis, urine samples will be collected before and up to 72 hours after the administration of UP-818-CC to determine UP-818-CC urine concentrations.
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start14 Feb 2022
- Primary completion12 Jan 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- EnliTISA (Shanghai) Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355621
- Sponsor's protocol ID
- UP-19-818-21002
- Acronym
- UP-818-CC
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The result of this trial has no plan to be published in International Committee of Medical Journal.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of UP-818-CC Injection in Healthy Chinese Subjects After Single-dose and Multiple-dose Intravenous Infusion
- ClinicalTrials.gov ID
- NCT07355621
- Acronym / sponsor ID
- UP-818-CC / UP-19-818-21002
- Conditions
- Healthy Subjects
- Keywords
- UP-818-CC injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- EnliTISA (Shanghai) Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 21 Jan 2026 (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.
The objectives of this study are to evaluate the safety, tolerability and pharmacokinetic characteristics in healthy Chinese volunteers after single and multiple dose of intravenous infusion of UP-818-CC.
This study is divided into two parts, single ascending dose part (SAD) and multiple ascending dose part (MAD), both conducted in healthy subjects, using a randomized, double-blind, placebo-controlled, dose-escalating design.
The SAD part is planned to be carried out in 6 dose groups. A total of about 43 healthy adult subjects are planned to be included. All subjects will receive a single dose on the first day (D1).
According to the obtained PK and safety information of the SAD, three appropriate dose groups are selected in MAD. A total of about 30 healthy adult subjects, both male and female, will be included. All subjects will receive multiple doses from D1 to D7, once daily.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UP-818-CC group | Experimental | Drug: UP-818-CC injectionsingle or multiple intravenous UP-818-CC injection |
| placebo group | Placebo comparator | Other: Placebosingle or multiple intravenous placebo injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) in the range of 19 to 26, including boundary values, BMI = weight (kg) / height (m) 2;
- The medical history, physical examination, laboratory items and tests related to the trial are all normal or abnormal and have no clinical significance, and the clinical research doctor judges that they are qualified;
- During the trial and within 3 months after the trial, the subjects or their spouses voluntarily took effective contraceptive measures, such as abstinence, condoms, the use of intrauterine devices, double-barrier methods (such as condoms and contraceptive diaphragms), etc., female subjects enter the trial after confirming the menstrual period; male subjects have no sperm donation plan;
- Be able to communicate well with researchers, fully understand the purpose and requirements of this trial, voluntarily participate in clinical trials and sign written informed consent.
Key exclusion criteria (20 listed)
- Those who are allergic to any active ingredient of the investigational drug or any excipient or excipient;
- Allergies (including bronchial asthma or asthmatic bronchitis, allergic rhinitis and other multiple drug or food allergies, etc.) or the total IgE results of the screening period showed allergies;
- Those with past or current diseases that the investigator considers ineligible to enroll, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, genitourinary system, metabolism and bone, or those with a history of allergic diseases or malignant tumors;
- Past or current chronic obstructive pulmonary disease, active pulmonary tuberculosis (including but not limited to increased erythrocyte sedimentation rate or a positive T-cell spot test for tuberculosis infection in the screening period or abnormal and clinically significant chest CT examination in the screening period, judged by the investigator afterwards, only those with calcifications and no clinically significant symptoms on lung imaging examinations can be enrolled) and other respiratory diseases;
- Patients with acute infection within 2 weeks before screening;
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 |
|---|---|---|
| UP-818-CC injectionUP-818-CC injection | Drug | UP-818-CC group |
| Placeboplacebo | Other | placebo group |
Primary outcome
Number of Participants with Treatment-Related Adverse Events as coded by MedDRA and assessed by CTCAE v5.0
Time frame: From baseline to Day4 in single dose groups, from baseline to Day 10 in multi-dose groups.
Number of Participants with Treatment-Related Adverse Events following administration of UP-818-CC injection.
8 secondary outcomes
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (maximum observed drug concentration)
Time frame: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (area under the curve)
Time frame: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (time to reach maximum drug concentration)
Time frame: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (area under the drug-time curve at 0 to infinity time)
Time frame: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (elimination half-life)
Time frame: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (clearance rate)
Time frame: Up to 72 hours
Plasma pharmacokinetic (PK) parameters of UP-818-CC injection (apparent volume of distribution)
Time frame: Up to 72 hours
Urine pharmacokinetic parameters of UP-818-CC following a single-dose and multiple-doses of UP-818-CC injection (the drug concentration).
Time frame: Up to 72 hours
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 21 Jan 2026.
- Individual participant dataSharing planned: No. The result of this trial has no plan to be published in International Committee of Medical Journal.
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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 UP-818-CC injection in people with Healthy Subjects, run by EnliTISA (Shanghai) Pharmaceutical Co., Ltd. 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 20 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 21 Jan 2026. 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?
Number of Participants with Treatment-Related Adverse Events as coded by MedDRA and assessed by CTCAE v5.0 (time frame: From baseline to Day4 in single dose groups, from baseline to Day 10 in multi-dose groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.