Safety, Tolerability and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: ABBV-066

• Registration Number: NCT02596217
• Lead Sponsor: AbbVie

Brief Summary

Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066 (risankizumab) in healthy Chinese, Japanese and Caucasian male volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-04
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo IV (Stage2)	Placebo	Placebo administered by intraveneous (IV) infusion
Stage 1 (medium dose SC)	ABBV-066	Medium dose administered by subcutaneous (SC) injection
Placebo SC (Stage1)	Placebo	Placebo administered by subcutaneous (SC) injection
Stage 2 (low dose IV)	ABBV-066	Low dose administered by intraveneous (IV) infusion
Stage 2 (medium dose IV)	ABBV-066	Medium dose administered by intraveneous (IV) infusion
Stage 2 (high dose IV)	ABBV-066	High dose administered by intraveneous (IV) infusion
Stage 1 (low dose SC)	ABBV-066	Low dose administered by subcutaneous (SC) injection
Stage 1 (high dose SC)	ABBV-066	High dose administered by subcutaneous (SC) injection

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with drug-related adverse events	Up to 144 days after screening

Secondary Outcome Measures

Name	Time	Method
Time from dosing to the maximum plasma concentration of the analyte in plasma (tmax)	Up to 144 days after randomization
Terminal half-life of the analyte in plasma (t1/2)	Up to 144 days after randomization
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of the last quantifiable plasma concentration (AUC0-tz)	Up to 144 days after randomization
Maximum measured plasma concentration of the analyte in plasma (Cmax)	Up to 144 days after randomization
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)	Up to 144 days after randomization

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇰🇷 Busan, Korea, Republic of