NCT06022354

To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects

A Single-center, Randomized, Double-blind, Sponsor Open, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 After Single and Multiple Subcutaneous Injections in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled trial of SIM0278 in healthy subjects. The study will be conducted in 2 parts. Part 1 is single ascending dose study. Part 2 is multiple ascending dose study.

Detailed description

The study will assess the safety, tolerability, and pharmacokinetics（PK） after a single or multiple administration of SIM0278 or placebo via subcutaneous injection in healthy subjects (male or female) where PK, pharmacodynamics (PD) and biomarkers will be assessed. Approximately 68 subjects (up to 84) will be enrolled in the whole study. The ratio of active drug to placebo in each dose level will be 3:1. In part1, approximately 44 subjects (up to 52) will be enrolled for the single dose escalation. Six dose levels are planned in part 1. In part2, approximately 24 (up to 32) subjects will be enrolled for the multiple dose escalation. Three dose levels are planned in part 2.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SIM0278 Injection/Placebo	SIM0278 Injection/Placebo

Timeline

• Start date: 2023-08-23
• Primary completion: 2025-03-18
• Completion: 2025-07-22
• First posted: 2023-09-01
• Last updated: 2025-09-11

Locations

1 site across 1 country: China