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

NCT07337044 PHASE1 COMPLETED

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)

Details

Lead sponsor	EnliTISA (Shanghai) Pharmaceutical Co., Ltd.
Phase	PHASE1
Status	COMPLETED
Enrolment	49
Start date	Wed Jan 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Oct 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Healthy Subjects

Interventions

• TISA-818-Inj
• Placebo

Countries

Sweden