Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese

• Status: Not yet recruiting
• Trial end date: 2023-07-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I clinical bridging trial, randomized，double-blind，placebo-controlled，single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety,tolerability,pharmacokynetics,pharmacodynamices, and food effect in healthy subjects。

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cascade Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

1. Healthy adult subjects of 18 years to 55 years

2. Weight:Male≥50kg ，female≥45kg BMI：18~32kg/m²

3. In good health, determined by having no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluation -1. Subject signs IFC and dates it

4. Subject must understand and follow test procedures and restrictions

Exclusion Criteria:

1. Subjects with special dietary requirements and cannot follow a uniform diet.

2. Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.

3. Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2.

4. History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.