NCT05259189

A Study of NBL-012 in Healthy Chinese Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NBL-012 in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: NovaRock Biotherapeutics, Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics (PK) of NBL-012 as single ascending doses (SAD) administered subcutaneously to healthy Chinese subjects.

Detailed description

This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics of NBL-012 administered subcutaneously as single ascending doses (SAD) to healthy Chinese subjects. Six dose cohorts will be intended for enrollment. The first dose will be sentinel group which will consist of 2 subjects, both of whom will receive active NBL-012. For subsequent dose cohorts, subjects will be given a single escalating SC dose of NBL-01

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	NBL-012 Injection	a single subcutaneous injection
DRUG	Placebo	a single subcutaneous injection

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-05-23
• Completion: 2022-05-23
• First posted: 2022-02-28
• Last updated: 2022-07-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study