Phase I Study of AbGn-168H in Healthy Male Volunteers

NCT01378364 | Completed Phase 1

• 2 other identifiers: 1304.12011-000713-39
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate safety, tolerability and pharmacokinetics of single rising doses of AbGn-168H administered by intravenous infusion or subcutaneous injection to healthy male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability will be assessed in a descriptive way based on: Physical examination, vital sign, 12-lead ECG, clinical laboratory tests, adverse events, assessment of tolerability by investigator

  6 weeks

Secondary Outcomes (14)

• MRT sc (mean residence time of the analyte in the body after subcutaneous injection)

  6 weeks

• CL (total/apparent clearance of the analyte in plasma after intravascular administration)

  6 weeks

• CL/F (apparent clearance of the analyte in plasma after extravascular administration)

  6 weeks

• V z (apparent volume of distribution during the terminal phase delta z following an intravascular dose)

  6 weeks

• V z/F (apparent volume of distribution during the terminal phase delta z after extravascular administration)

  6 weeks

Study Arms (6)

AbGn-168H very low dose i.v.

EXPERIMENTAL

subject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo

Drug: AbGn-168H; Drug: Placebo

AbGn-168H low dose i.v.

EXPERIMENTAL

subject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo

Drug: AbGn-168H; Drug: Placebo

AbGn-168H medium dose i.v.

EXPERIMENTAL

subject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo

Drug: Placebo; Drug: AbGn-168H

AbGn-168H high dose i.v.

EXPERIMENTAL

subject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo

Drug: Placebo; Drug: AbGn-168H

AbGn-168H very low dose s.c.

EXPERIMENTAL

subject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo

Drug: AbGn-168H; Drug: Placebo

AbGn-168H medium dose s.c.

EXPERIMENTAL

subject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo

Drug: Placebo; Drug: AbGn-168H

Interventions

AbGn-168H DRUG

single very low dose of AbGn-168H i.v.

AbGn-168H very low dose i.v.

Placebo DRUG

single dose of Placebo i.v.

AbGn-168H very low dose i.v.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males according to following criteria:
• Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)) within normal range, 12-lead electrocardiogram (ECG), clinical laboratory tests
• Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease in the opinion of the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological and hormonal disorders
• Chronic or relevant acute infections including hepatitis and tuberculosis, or a positive PPD skin test (5 mm or greater) at screening or within the previous 3 months
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Use of biologic agents within 12 weeks prior to treatment

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1304.1.4901 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 22, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2011
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DE (1)