Study design and patients
This was a phase 2a, 7-center, open-labeled, non-randomized and positive controlled clinical trial. The study consisted of two parts: part 1, dose escalation and part 2, dose expansion. The trial was registered at clinicaltrials.gov (NCT03698617).The inclusion criteria for participants were: 18–65 years old; non-pregnant and non-lactating if female; body mass index (BMI) 19–30 kg/m