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

Study Overview
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Brief Summary
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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.

Official Title
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Safety, Tolerability and Pharmacokinetics Study of Single Rising Doses of AbGn-168H Administered by Intravenous Infusion (125 μg/kg, 500 μg/kg, 1 mg/kg, 2 mg/kg) or Subcutaneous Injection (125 μg/kg, 1 mg/kg) to Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

Conditions
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Healthy

Intervention / Treatment
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* Drug: AbGn-168H
* Drug: AbGn-168H
* Drug: Placebo
* Drug: Placebo
* Drug: Placebo
* Drug: Placebo
* Drug: AbGn-168H
* Drug: AbGn-168H
* Drug: AbGn-168H
* Drug: Placebo
* Drug: Placebo
* Drug: AbGn-168H


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AbGn-168H very low dose i.v.<br>subject to receive a single very low dose of AbGn-168H intravenously (i.v.) or placebo | Drug: AbGn-168H<br>* single very low dose of AbGn-168H i.v.<br>Drug: Placebo<br>* single dose of Placebo i.v.<br>|
| Experimental: AbGn-168H low dose i.v.<br>subject to receive a single low dose of AbGn-168H intravenously (i.v.) or placebo | Drug: AbGn-168H<br>* single low dose of AbGn-168H i.v.<br>Drug: Placebo<br>* single dose of Placebo i.v.<br>|
| Experimental: AbGn-168H medium dose i.v.<br>subject to receive a single medium dose of AbGn-168H intravenously (i.v.) or placebo | Drug: Placebo<br>* single dose of Placebo i.v.<br>Drug: AbGn-168H<br>* single medium dose of AbGn-168H i.v.<br>|
| Experimental: AbGn-168H high dose i.v.<br>subject to receive a single high dose of AbGn-168H intravenously (i.v.) or placebo | Drug: Placebo<br>* single dose of Placebo i.v.<br>Drug: AbGn-168H<br>* single high dose of AbGn-168H i.v.<br>|
| Experimental: AbGn-168H very low dose s.c.<br>subject to receive a single very low dose of AbGn-168H subcutaneously (s.c.) or placebo | Drug: AbGn-168H<br>* single low dose of AbGn-168H s.c.<br>Drug: Placebo<br>* single dose of Placebo s.c.<br>|
| Experimental: AbGn-168H medium dose s.c.<br>subject to receive a single medium dose dose of AbGn-168H subcutaneously (s.c.) or placebo | Drug: Placebo<br>* single dose of Placebo s.c.<br>Drug: AbGn-168H<br>* single medium dose of AbGn-168H s.c.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| V ss (apparent volume of distribution at steady state following intravascular administration) |  | 6 weeks | 
| C max (maximum measured concentration of the analyte in plasma) |  | 6 weeks | 
| t max (time from dosing to maximum measured concentration) |  | 6 weeks | 
| AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |  | 6 weeks | 
| AUC 0-tz: The area under the plasma concentration-time curve over the time interval from 0 to the last timepoint at which concentrations of AbGn-168H can be measured |  | 6 weeks | 
| %AUC tz-infinity: The percentage of the AUC0-infinity obtained by extrapolation from the last evaluable timepoint |  | 6 weeks | 
| delta z (terminal rate constant in plasma) |  | 6 weeks | 
| t 1/2 (terminal half-life of the analyte in plasma) |  | 6 weeks | 
| MRT iv (mean residence time of the analyte in the body after intravenous injection or infusion) |  | 6 weeks |