Overview

This trial has been completed.

Condition healthy
Treatments bi 695501 prefilled syringe, bi 695501 autoinjector
Phase phase 1
Sponsor Boehringer Ingelheim
Start date October 2015
End date May 2016
Trial size 66 participants
Trial identifier NCT02606903, 1297.6, 2015-003029-32

Summary

To investigate and compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bi 695501 prefilled syringe
(Experimental)
bi 695501 autoinjector

Primary Outcomes

Measure
Cmax
time frame: 0 to 1032 hours after dose
AUC 0-1032
time frame: 0 to 1032 hours after dose
AUC 0-inf
time frame: 0 to 1032 hours after dose

Secondary Outcomes

Measure
Number (proportion) of subjects with drug-related AEs
time frame: Day 1 through Day 70

Eligibility Criteria

Male participants from 18 years up to 65 years old.

Inclusion criteria: - Healthy male, non-athletic* Caucasian subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure [BP], pulse rate [PR]), 12-lead ECG, and clinical laboratory tests. - Age between 18 and 65 years (inclusive) - BMI of 18 to 30 kg/m2 (inclusive) - BMI 18 to <20, or - BMI 20 to <25, or - BMI 25 to <=30 - Signed and dated written informed consent prior to admission to the trial in accordance with Good Clinical Practice (GCP) and local legislation. - Subjects agree to use an acceptable method of contraception during the trial and for 6 month after the dose of trial drug. - Non-athletic defined as person performing no more than one hour of exercise per week Exclusion criteria: - Any finding in the medical examination (including BP, PR or ECG) that deviates from normal and judged as clinically relevant by the investigator. - Any evidence of a concomitant disease judged as clinically relevant by the investigator including gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders or diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders. - History of relevant orthostatic hypotension, fainting spells, or blackouts. - Chronic or relevant acute infections. - Positive result for HIV, HBV, and hepatitis C (Hep C) at screening. - History of relevant allergy or hypersensitivity including allergy to the trial medication, its excipients or device materials (e.g. natural rubber or latex). - Intake of drugs with a long half-life (more than 24 hours) within 30 days or less than 5 half-lives of the respective drug prior to administration of trial medication. - Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial. - Previous exposure to a biologic drug. - Intake of an investigational drug in another trial within 2 months prior to intake of trial medication in this trial or intake of an investigational drug during the course of this trial. - Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day). - Inability to refrain from smoking during days of confinement at the trial site. - Alcohol abuse (consumption of more than 4 units/day). - Unwillingness/inability to refrain from intake of alcoholic beverages from 48 hours prior to the trial medication administration and until Day 14 post trial medication administration; and/or to limit alcohol intake to a maximum of 3 units per day until e.o.t. - Drug abuse or positive drug screening. - Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial. - Intention to perform excessive physical activities within 1 week prior to administration of trial medication or contact sport during the entire trial and unwilling to avoid vigorous exercise for 14 days post dosing. - Inability to comply with dietary regimen of trial site. - Any out-of-range laboratory values considered clinically significant by the investigator; subjects with creatine kinase (CK) values 2 times the upper limit of normal (ULN) at Day -1 are excluded from participation. - Subject is assessed as unsuitable for inclusion by the investigator, for instance, because he is considered not able to understand and comply with trial requirements, or has a condition that would not allow safe participation in the trial. - Subjects with any immunological disorders or auto-immune disorders, (e.g., RA, lupus erythematosus, scleroderma, etc.). - Subject has received a live vaccine within 12 weeks prior to enrolling in the trial. - History of TB or positive finding in IGRA. - Evidence of skin irritation or infection at the planned injection place.

Additional Information

Official title Randomized, Single-dose, Parallel-arm, Open-label Phase I Trial to Investigate and Compare the Pharmacokinetics, Safety and Tolerability of BI 695501 Administered Subcutaneously Via Prefilled Syringe or Autoinjector
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.