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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AbGn-168H

Study type: Interventional

Funder types: Industry

Identifiers

NCT01378364

2011-000713-39 (EudraCT Number)

1304.1

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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

2. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2

3. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion criteria

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease in the opinion of the investigator
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological and hormonal disorders
4. 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
5. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
6. Use of biologic agents within 12 weeks prior to treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

48 participants in 6 patient groups

AbGn-168H very low dose i.v.

Experimental group

Description:

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

Treatment:

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

AbGn-168H low dose i.v.

Experimental group

Description:

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

Treatment:

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

AbGn-168H medium dose i.v.

Experimental group

Description:

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

Treatment:

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

AbGn-168H high dose i.v.

Experimental group

Description:

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

Treatment:

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

AbGn-168H very low dose s.c.

Experimental group

Description:

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

Treatment:

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

AbGn-168H medium dose s.c.

Experimental group

Description:

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

Treatment:

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: AbGn-168H

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: AbGn-168H

Drug: Placebo

Drug: Placebo