Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of QLS2319 in Healthy Subjects and Cancer Cachexia
This study is a first-in-human, dose-escalation trial in healthy adult participants and cancer cachexia to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of QLS2319. The target population of dose escalation part is healthy adult participants, and the dose expansion part will enroll patients with cancer cachexia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Sun-Yat-sen University Cancer Center
Guangzhou, China
Phase Ia:Safety and tolerability after a single subcutaneous injection of QLS2319/placebo
Incidence and severity of adverse events (AEs), assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v6.0)
Time frame: Up to Day 99
Phase Ib:Safety and tolerability after multiple subcutaneous injections of QLS2319
Incidence and severity of adverse events (AEs), assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v6.0)
Time frame: Up to 12 weeks
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