NCT04511624

Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

A Phase I Randomized, Double-Blind, Placebo-Controlled, Single Subcutaneous or Intravenous Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI112 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a the first in human study to evaluate the safety, tolerability, PK and PD of single subcutaneous or intravenous dose of IBI112 in healthy subjects

Detailed description

In this first in human, phase 1, randomized, double-blind, placebo-controlled study, a single subcutaneous or intravenous dose of IBI112 will be administered to 46 healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	IBI112 dose1	Drug: IBI112 SC dose1 Drug:placebo
DRUG	IBI112 dose2	Drug: IBI112 SC dose2 Drug:placebo
DRUG	IBI112 dose3	Drug: IBI112 SC dose3 Drug:placebo
DRUG	IBI112 dose4	Drug: IBI112 SC dose4 Drug:placebo
DRUG	IBI112 dose5	Drug: IBI112 IV dose5 Drug:placebo
DRUG	IBI112 dose6	Drug: IBI112 SC dose6 Drug:placebo
DRUG	IBI112 dose7	Drug: IBI112 IV dose7 Drug:placebo

Timeline

• Start date: 2020-08-27
• Primary completion: 2022-07-22
• Completion: 2022-07-22
• First posted: 2020-08-13
• Last updated: 2022-09-19

Locations

1 site across 1 country: China