NCT06501573

A Study of SGB-9768 in Adult Healthy Volunteers

A Phase 1, Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-9768 in Healthy Volunteers

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Suzhou Sanegene Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blind, placebo-controlled single ascending dose study of SGB-9768 in healthy volunteers. The purpose is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768.

Detailed description

It is a phase 1, randomized, double-blind, placebo-controlled single ascending dose study of SGB-9768. The primary objective is to evaluate the safety, tolerability of SGB-9768 when administered subcutaneously as a single dose to healthy volunteers. The secondary objective is to characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered SGB-9768 in healthy volunteers.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	SGB-9768	SGB-9768 for sc injection
OTHER	Placebo	sterile normal saline (0.9% NaCl) for sc injection

Timeline

• Start date: 2024-08-06
• Primary completion: 2025-05-03
• Completion: 2025-10-17
• First posted: 2024-07-15
• Last updated: 2025-01-22

Locations

1 site across 1 country: China