Assessment of CR6261, a Monoclonal Antibody Against the Influenza A Virus

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: CR6261 2 mg/kg; Biological: Placebo; Biological: CR6261 5 mg/kg; Biological: CR6261 30 mg/kg; Biological: CR6261 50 mg/kg; Biological: CR6261 15 mg/kg

• Registration Number: NCT01406418
• Lead Sponsor: Crucell Holland BV

Brief Summary

The purpose of this study is to assess in healthy subjects the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses of CR6261, a monoclonal antibody against influenza A viruses.

Detailed Description

This randomized, double-blind, placebo-controlled dose escalation study will enroll up to 6 cohorts of healthy subjects. Eight subjects will be enrolled in each cohort (1 to 5) and will receive a single 2-hour intravenous infusion of CR6261 (6 subjects) or placebo (2 subjects) on Day 1. Subjects will be dosed in pairs of two. Once all subjects in a cohort have completed Study Day 8, the preliminary safety data will be reviewed. Provided that no safety issues are identified, dose escalation to the subsequent cohort may be permitted.

To obtain additional data at the 30 mg/kg dose level, a sixth cohort will be enrolled after the preliminary safety and tolerability of the 30 mg/kg dose in Cohort 4 is demonstrated. Cohort 6 will be comprised of 24 subjects (randomized 5 : 1 to CR6261 or placebo) following the same visit schedule as subjects in Cohorts 1-5.

Study Timeline

• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-01
• Study Start: 2013-02
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: CR6261	CR6261 2 mg/kg	2 mg/kg CR6261
Cohort 1: Placebo	Placebo	5% dextrose in water
Cohort 2: CR6261	CR6261 5 mg/kg	5 mg/kg CR6261
Cohort 4: CR6261	CR6261 30 mg/kg	30 mg/kg CR6261
Cohort 5: CR6261	CR6261 50 mg/kg	50 mg/kg CR6261
Cohort 5: Placebo	Placebo	5% dextrose in water
Cohort 6: CR6261	CR6261 30 mg/kg	30 mg/kg CR6261
Cohort 6 Placebo	Placebo	5% dextrose in water
Cohort 2: Placebo	Placebo	5% dextrose in water
Cohort 3: CR6261	CR6261 15 mg/kg	15 mg/kg CR6261
Cohort 3: Placebo	Placebo	5% dextrose in water
Cohort 4: Placebo	Placebo	5% dextrose in water

Primary Outcome Measures

Name	Time	Method
Adverse events and changes in laboratory parameters and vital signs as measures of safety and tolerability of single escalating doses of CR6261	From baseline to 75 days post-dose

Secondary Outcome Measures

Name	Time	Method
Assessment of antibodies binding to CR6261 as a measure of immunogenicity of single escalating doses of CR6261	From baseline to 75 days post-dose
Assessment of pharmacokinetics of single escalating doses of CR6261	From baseline to 75 days post-dose	Pharmacokinetic parameters include area under the serum concentration-time curve from zero to the time of the last measurable concentration (AUC0-t), area under the serum concentration-time curve from zero to infinity (AUC0-inf), maximum concentration (Cmax), time of Cmax (tmax), systemic clearance (CL), terminal elimination half life (t1/2), etc.

Trial Locations

Locations (1)

Quintiles Early Clinical Development; 🇺🇸 Overland Park, Kansas, United States