Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Adult Subjects After Subcutaneous Injection of TISA-818-Inj

NCT07337044 | Completed Phase 1

• 1 other identifier: TISA-818-22101
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Phase 1 clinical study

Outcome Measures

Primary Outcomes (1)

• Frequency, intensity, and seriousness of Treatment Emergent Adverse Events

  Frequency, intensity, and seriousness of adverse events following subcutaneous injection of TISA-818.

  UP to 20 days

Secondary Outcomes (1)

• Plasma pharmacokinetic parameters of TISA-818 following a single-dose and multiple-doses of TISA-818 injection

  Up to 72 hours

Study Arms (2)

TISA-818-Inj group

EXPERIMENTAL

Drug: TISA-818-Inj

Placebo group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TISA-818-Inj DRUG

TISA-818-Inj

TISA-818-Inj group

Placebo DRUG

Placebo

Placebo group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• EnliTISA (Shanghai) Pharmaceutical Co., Ltd.: lead

Study Sites (1)

CTC Clinical Trial Consultants AB

Uppsala, Sweden

Location

Study Design

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

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 13, 2026
• Study Start: January 24, 2024
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)