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

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)

Timeline

Start

2024-01-24

Primary completion

2024-10-16

Completion

2024-10-16

Drugs

Indications

No indication recorded.