Healthy SubjectsPhase 1TISA-818-InjNCT07337044
Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Adult Subjects After Subcutaneous Injection of TISA-818-Inj
A Phase 1 study testing TISA-818-Inj in people with Healthy Subjects, run by EnliTISA (Shanghai) Pharmaceutical Co., Ltd. at 1 site in Sweden.
Trial summary
This is a single-centre, randomised, double-blind, placebo-controlled, dose escalation study to assess the safety, tolerability, and pharmacokinetic (PK) profile, of TISA-818-Inj-5mg/mL after single and multiple s.c. injections in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- TISA-818-Inj
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteSweden
- Study dates
- 24 Jan 2024to 16 Oct 2024
- 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
- Willing and able to give written informed consent for participation in the study.
- The subject is considered by the Investigator to be in good general health as determined by medical history, clinical laboratory test results, vital signs measurements, 12-lead ECG results, and physical examination findings at screening.
- For all women of childbearing potential (WOCBP) a negative pregnancy test at screening and a negative urine dip-stick pregnancy test at baseline, prior to first dose of Investigational medicinal product (IMP) will be required.
- Females of non-childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal (defined as 12 months of amenorrhoea [in questionable cases a blood sample with follicle stimulating hormone (FSH) 25-140 IE/L is confirmatory]).
- WOCBP must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy from at least 4 weeks prior to dose until 30 days after (last) IMP administration. Their male partner must agree to use a condom during the same time frame.
- Fertile male subjects must be willing to use condom and assure that their fertile female partner will use contraceptive methods with a failure rate of < 1% 12 to prevent pregnancy and drug exposure of a fertile female partner and refrain from donating sperm from the date of dosing until 30 days after dosing of the IMP. Men who are surgically sterile may be included without they/their partner fulfilling the above criteria on birth control.
Who cannot join
- Current evidence or history of clinically significant (as judged by the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including asthma, chronic obstructive pulmonary disease [COPD] and drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the study.
- History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity (such as seasonal allergy, pet allergy, allergy to a different class of drug etc.), as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to TISA-818.
- History of severe COVID-19 infection requiring hospitalisation within the last 12 months prior to screening, or clinical history compatible with Long COVID-19 (symptoms beyond 12 weeks of acute infection).
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- Administration of a live viral vaccine (e.g. measles-mumps-rubella, varicella zoster, herpes zoster, oral polio virus, FluMist, attenuated typhoid fever vaccine, or attenuated rotavirus vaccine) within 8 weeks prior to screening and/or is unwilling to avoid live viral vaccines for at-least 8 weeks following completion of the final study visit.
- Prolonged QTcF (>450 ms for men, >470 ms for women), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- After 10 min supine rest at the time of screening, any vital signs values outside the following ranges:
- Systolic blood pressure < 90 mmHg or ≥ 140 mmHg, or
- Diastolic blood pressure < 50 mmHg or ≥ 90 mmHg, or
- Pulse <40 or >90 beats per min (bpm)
- Any positive result on screening for human immunodeficiency virus (HIV), hepatitis B (serum hepatitis B surface antigen positive), hepatitis C (e.g. HCV RNA positive).
- Any clinically significant abnormal safety laboratory values, as judged by the Investigator.
- Current smoker or user of nicotine products. Irregular use of nicotine (e.g. smoking, snuffing, chewing tobacco) less than three times per week is allowed before Day -1.
- Positive screening result for drugs of abuse or alcohol at the time of screening or on admission to the clinic prior to administration of the IMP.
- Subjects who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the study.
- History of binge drinking or frequent alcohol consumption within 6 months prior to the study (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).
- Any present or historic use of drugs of abuse or anabolic steroids.
- Frequent excessive consumption of tea, coffee, or caffeinated beverages (more than 5 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 randomisation.
- Inability to be venepunctured and/or tolerate venous access.
- Inability or un-willingness to be administered the number of s.c. injections to be given in applicable dose cohort (e.g. afraid of needled/sticks, unhealthy skin, or too skinny), as judged by the Investigator.
- Blood donation (or corresponding blood loss) ≥ 450 mL of blood within 3 months before Day -1 (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.
- Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins, and minerals within 2 weeks prior to (first) administration of IMP. Use of montelukast sodium and other leukotriene receptor inhibitors is not allowed during the same period.
- Any medications or herbal remedies, including St John's Wort, known to chronically alter drug absorption or elimination processes within 4 weeks prior to first IMP administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
- Administration of another new chemical entity (defined as a compound that has not been approved for marketing) or has participated in any other clinical study that included drug treatment with the last administration within 3 months prior to administration of IMP in this study. Subjects consented and screened but not dosed in previous phase 1 studies are not excluded.
- Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Adult Subjects After Subcutaneous Injection of TISA-818-Inj
This is a single-centre, randomised, double-blind, placebo-controlled, dose escalation study to assess the safety, tolerability, and pharmacokinetic (PK) profile, of TISA-818-Inj-5mg/mL after single and multiple s.c. injections in healthy subjects.
The study consisted of two parts： Part A: Single ascending dose (SAD) in healthy adult subjects (3 dose cohorts, 6 active and 2 placebo/cohort) Part B: Multiple ascending dose (MAD) with 7 days once daily administration in healthy adult subjects (3 dose cohorts, 6 active and 2 placebo/cohort)
- Conditions
- Healthy Subjects
- Being tested
- TISA-818-Inj, Placebo
- Keywords
- Phase 1 clinical study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TISA-818-InjDrug
TISA-818-Inj
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TISA-818-Inj group | Experimental | Not described Receives: Drug: TISA-818-Inj |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, intensity, and seriousness of Treatment Emergent Adverse Events
Frequency, intensity, and seriousness of adverse events following subcutaneous injection of TISA-818.
Measured: UP to 20 days
Secondary outcomes (1)
Plasma pharmacokinetic parameters of TISA-818 following a single-dose and multiple-doses of TISA-818 injection
For PK analysis, blood samples will be collected before and up to 72 hours after the subcutaneous injection of TISA-818 to determine TISA-818 serum 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 posted13 Jan 2026
- Study start24 Jan 2024
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
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
- 49 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
- NCT07337044
- Sponsor's protocol ID
- TISA-818-22101
- Acronym
- TISA-818-Inj
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The result of this trial will not be published in the International Committee of Medical Journal.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Adult Subjects After Subcutaneous Injection of TISA-818-Inj
- ClinicalTrials.gov ID
- NCT07337044
- Acronym / sponsor ID
- TISA-818-Inj / TISA-818-22101
- Conditions
- Healthy Subjects
- Keywords
- Phase 1 clinical study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- EnliTISA (Shanghai) Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 13 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.
This is a single-centre, randomised, double-blind, placebo-controlled, dose escalation study to assess the safety, tolerability, and pharmacokinetic (PK) profile, of TISA-818-Inj-5mg/mL after single and multiple s.c. injections in healthy subjects.
The study consisted of two parts： Part A: Single ascending dose (SAD) in healthy adult subjects (3 dose cohorts, 6 active and 2 placebo/cohort) Part B: Multiple ascending dose (MAD) with 7 days once daily administration in healthy adult subjects (3 dose cohorts, 6 active and 2 placebo/cohort)
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 |
|---|---|---|
| TISA-818-Inj group | Experimental | Drug: TISA-818-Inj |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing and able to give written informed consent for participation in the study.
- The subject is considered by the Investigator to be in good general health as determined by medical history, clinical laboratory test results, vital signs measurements, 12-lead ECG results, and physical examination findings at screening.
- For all women of childbearing potential (WOCBP) a negative pregnancy test at screening and a negative urine dip-stick pregnancy test at baseline, prior to first dose of Investigational medicinal product (IMP) will be required.
- Females of non-childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal (defined as 12 months of amenorrhoea [in questionable cases a blood sample with follicle stimulating hormone (FSH) 25-140 IE/L is confirmatory]).
- WOCBP must agree to use a highly effective method of contraception with a failure rate of < 1% to prevent pregnancy from at least 4 weeks prior to dose until 30 days after (last) IMP administration. Their male partner must agree to use a condom during the same time frame.
Key exclusion criteria (27 listed)
- Current evidence or history of clinically significant (as judged by the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including asthma, chronic obstructive pulmonary disease [COPD] and drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
- Any planned major surgery within the duration of the study.
- History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity (such as seasonal allergy, pet allergy, allergy to a different class of drug etc.), as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to TISA-818.
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 |
|---|---|---|
| TISA-818-InjTISA-818-Inj | Drug | TISA-818-Inj group |
| PlaceboPlacebo | Drug | Placebo group |
Primary outcome
Frequency, intensity, and seriousness of Treatment Emergent Adverse Events
Time frame: UP to 20 days
Frequency, intensity, and seriousness of adverse events following subcutaneous injection of TISA-818.
1 secondary outcome
Plasma pharmacokinetic parameters of TISA-818 following a single-dose and multiple-doses of TISA-818 injection
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 13 Jan 2026.
- Individual participant dataSharing planned: No. The result of this trial will not be published in the 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 TISA-818-Inj in people with Healthy Subjects, run by EnliTISA (Shanghai) Pharmaceutical Co., Ltd. at 1 site in Sweden.
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 6 inclusion and 27 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 13 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 Sweden. 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?
Frequency, intensity, and seriousness of Treatment Emergent Adverse Events (time frame: UP to 20 days). 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 13 Jan 2026.