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

NCT07337044 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-01-13

No results posted yet for this study

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

Interventions

DRUG

TISA-818-Inj

TISA-818-Inj

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • EnliTISA (Shanghai) Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-24
Primary Completion
2024-10-16
Completion
2024-10-16

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07337044 on ClinicalTrials.gov