Clinical Trial

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

Study acronym: TISA-818-Inj
Completed Phase 1
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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)
Trial Details
NCT Number NCT07337044
Lead Sponsor EnliTISA (Shanghai) Pharmaceutical Co., Ltd.
Conditions Healthy Subjects
Enrollment 49 participants
Start Date 2024-01-24
Primary Completion 2024-10-16 (estimated)
Study Completion 2024-10-16 (estimated)
Updated on ClinicalTrials.gov 2026-01-13