HealthyPhase 1NCT02899338

Pharmacokinetics and Safety of BI 695501

A Phase 1 study testing BI695501 Prefilled syringe and BI695501Autoinjector in people with Healthy, run by Boehringer Ingelheim at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after single injection using either auto injector or prefilled syringe. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI695501 Prefilled syringe and BI695501Autoinjector
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 162 participants
Where: 2 sitesin 2 countries
Study dates: 21 Sep 2016to 23 Feb 2017
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age between 18 and 65 years (inclusive)
BMI of >17.5 to <35.0 kg/m2
Healthy male or female 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.
Subjects who meet any of the following criteria:
Surgically sterilized (confirmed 6 month prior to enrollment)
Have surgically sterilized sexual partner (confirmed 6 month prior to enrollment)

Show all 9Show fewer

Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
Subjects agree to use an adequate contraception, starting from the begin of the trial and until 6 months after the dose of the trial drug: e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to admission to the trial

Who cannot join

Previous exposure to adalimumab or proposed adalimumab biosimilar drugs.
Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (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, hepatitis B virus (HBV), and hepatitis C (Hep C) at screening.

Show all 24Show fewer

History of relevant allergy or hypersensitivity including allergy to the trial medication, its excipients or device materials (e.g. natural rubber or latex).
Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial.
Intake of an investigational drug in another trial within 2 months or 5 half-lives (whichever longer) prior to planned administration of the trial medication in this trial or intake of an investigational drug during the course of this trial.
Alcohol abuse (consumption of more than 28 units/week).
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 500 mL within 30 days prior to administration of trial medication or intended donation during the trial.
Intention to perform excessive physical activities within 4days 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 to be 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., Rheumatoid arthritis (RA), lupus erythematosus, scleroderma, etc.).
Subject has received a live vaccine within 12 weeks prior to enrolling in the trial.
History of tuberculosis (TB) or positive finding in Interferon-gamma release assay (IGRA).
Evidence of skin irritation or infection at the planned injection place.
Currently enrolled in another investigational device or drug study
Any condition that, in the investigator´s opinion, makes them an unreliable study subject or unlikely to complete the trial
Women who are pregnant, nursing, or who plan to become pregnant while in the trial

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Belgium1 site

SGS Life Sciences Services
Antwerp, 2060

Other trials in Belgium

Netherlands1 site

PRA Health Sciences Onderzoekscentrum Martini
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: Randomized, Single-dose, Parallel-arm, Open-label Phase I Trial to Compare the Pharmacokinetics, Safety and Tolerability of BI 695501 Administered Subcutaneously Via Prefilled Syringe or Autoinjector

To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after single injection using either auto injector or prefilled syringe.

Conditions: Healthy
Being tested: BI695501 Prefilled syringe, BI695501Autoinjector

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI695501 Prefilled syringeDrug
BI695501AutoinjectorDrug

Study groups in NCT02899338
Study group	Role	What they receive
BI695501 Autoinjector	Experimental	Not described Receives: Drug: BI695501Autoinjector
BI695501 Prefilled syringe	Active comparator	Not described Receives: Drug: BI695501 Prefilled syringe

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 to 1368 Hours (AUC0-1368) After Administration Via PFS and AI.
The AUC0-1368 of 40 mg BI 695501 administered via PFS and AI was measured. Plasma concentrations were measured using a validated enzyme-linked immunosorbent assay (ELISA). Only concentration values within the validated concentration range of 0.025 to 2.0 micrograms per millilitre (µg/mL) and actual sampling times were used.
Measured: From 0 to 1368 hours post-dose. Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.
The Maximum Measured Concentration of BI 695501 in Plasma (Cmax) After Administration Via PFS and AI
The Cmax of 40 mg BI 695501 administered via PFS and AI. Plasma concentrations were measured using a validated ELISA. Only concentration values within the validated concentration range of 0.025 to 2.0 µg/mL and actual sampling times were used.
Measured: From 0 to 1368 hours post-dose. Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.
Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) After Administration Via PFS and AI.
The AUC0-∞ of 40 mg BI 695501 administered via PFS and AI. Plasma concentrations were measured using a validated ELISA. Only concentration values within the validated concentration range of 0.025 to 2.0 µg/mL and actual sampling times were used.
Measured: Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.

Secondary outcomes (1)

The Percentage of Subjects With Drug-related Treatment-emergent Adverse Events (TEAEs) From Day 1 to Day 70.
A treatment-related TEAE was defined as any TEAE assessed by the Investigator as related to the trial medication. A TEAE was defined as an adverse event (AE) that started or worsened in severity on or after the single dose of trial medication up to 10 weeks (70 days) post-dose.
Measured: From Day 1 to Day 70

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 201623 Feb 2017

First posted14 Sep 2016 (estimated)
Study start21 Sep 2016
Primary completion9 Feb 2017
Study completion23 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02899338
Sponsor's protocol ID: 1297.13
Other IDs: 2016-003158-34, 2016
Status last verified: Oct 2018
First submitted: 9 Sep 2016
Last updated: 11 Oct 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Single-dose, Parallel-arm, Open-label Phase I Trial to Compare the Pharmacokinetics, Safety and Tolerability of BI 695501 Administered Subcutaneously Via Prefilled Syringe or Autoinjector
ClinicalTrials.gov ID: NCT02899338
Acronym / sponsor ID: 1297.13
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 21 Sep 2016 (actual)
Primary completion: 9 Feb 2017 (actual)
Study completion: 23 Feb 2017 (actual)
First posted: 14 Sep 2016 (estimated)
Results: Posted 11 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after single injection using either auto injector or prefilled syringe.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BI695501 Autoinjector	Experimental	Drug: BI695501Autoinjector
BI695501 Prefilled syringe	Active comparator	Drug: BI695501 Prefilled syringe

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age between 18 and 65 years (inclusive)
BMI of >17.5 to <35.0 kg/m2
Healthy male or female 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.
Subjects who meet any of the following criteria:
Subjects agree to use an adequate contraception, starting from the begin of the trial and until 6 months after the dose of the trial drug: e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device

Key exclusion criteria (24 listed)

Previous exposure to adalimumab or proposed adalimumab biosimilar drugs.
Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI695501 Prefilled syringe	Drug	BI695501 Prefilled syringe
BI695501Autoinjector	Drug	BI695501 Autoinjector

Primary outcome

Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 to 1368 Hours (AUC0-1368) After Administration Via PFS and AI.
Time frame: From 0 to 1368 hours post-dose. Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.
The AUC0-1368 of 40 mg BI 695501 administered via PFS and AI was measured. Plasma concentrations were measured using a validated enzyme-linked immunosorbent assay (ELISA). Only concentration values within the validated concentration range of 0.025 to 2.0 micrograms per millilitre (µg/mL) and actual sampling times were used.
The Maximum Measured Concentration of BI 695501 in Plasma (Cmax) After Administration Via PFS and AI
Time frame: From 0 to 1368 hours post-dose. Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.
The Cmax of 40 mg BI 695501 administered via PFS and AI. Plasma concentrations were measured using a validated ELISA. Only concentration values within the validated concentration range of 0.025 to 2.0 µg/mL and actual sampling times were used.
Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) After Administration Via PFS and AI.
Time frame: Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.
The AUC0-∞ of 40 mg BI 695501 administered via PFS and AI. Plasma concentrations were measured using a validated ELISA. Only concentration values within the validated concentration range of 0.025 to 2.0 µg/mL and actual sampling times were used.

1 secondary outcome

The Percentage of Subjects With Drug-related Treatment-emergent Adverse Events (TEAEs) From Day 1 to Day 70.
Time frame: From Day 1 to Day 70

Results and safety

Results posted to the registry on 11 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI695501 Prefilled Syringe	81	78
BI695501 Autoinjector	81	79

Primary outcome: Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 to 1368 Hours (AUC0-1368) After Administration Via PFS and AI.

Time frame: From 0 to 1368 hours post-dose. Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.. Geometric mean (Geometric Coefficient of Variation). Unit: microgram hour per milliliter (μg*h/mL)

Measure	BI695501 Prefilled Syringe n = 76	BI695501 Autoinjector n = 79
Value	2100 (43.9)	2150 (45.2)

BI695501 Prefilled Syringe vs BI695501 Autoinjector: Adjusted geometric mean ratio: 101.71 (90% CI 91.31 to 113.29), ANOVA

Population analysed: PKS: The pharmacokinetic set (PKS) consisted of all randomized subjects who received the single dose of trial medication (BI 695501 administered via PFS or AI), had at least 1 evaluable primary PK parameter, and were without important protocol deviations or violations thought to significantly affect the PK of BI 695501.

Primary outcome: The Maximum Measured Concentration of BI 695501 in Plasma (Cmax) After Administration Via PFS and AI

Measure	BI695501 Prefilled Syringe n = 79	BI695501 Autoinjector n = 81
Value	3.86 (27.8)	3.86 (23.6)

BI695501 Prefilled Syringe vs BI695501 Autoinjector: Adjusted geometric mean ratio: 100.11 (90% CI 94.17 to 106.43), ANOVA

Population analysed: PKS

Primary outcome: Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) After Administration Via PFS and AI.

Time frame: Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.. Geometric mean (Geometric Coefficient of Variation). Unit: μg*h/mL

Measure	BI695501 Prefilled Syringe n = 76	BI695501 Autoinjector n = 79
Value	2250 (50.3)	2330 (50.4)

BI695501 Prefilled Syringe vs BI695501 Autoinjector: Adjusted geometric mean ratio: 103.19 (90% CI 91.38 to 116.53), ANOVA

Population analysed: PKS

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From single dose administration till 10 weeks; up to 70 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI695501 Autoinjector	2 of 81 (2.5%)	47 of 81 (58%)	0 of 81
BI695501 Prefilled Syringe	1 of 81 (1.2%)	41 of 81 (50.6%)	0 of 81

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Synopsis LinkLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI695501 Prefilled syringe and BI695501Autoinjector in people with Healthy, run by Boehringer Ingelheim at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 to 1368 Hours (AUC0-1368) After Administration Via PFS and AI. (time frame: From 0 to 1368 hours post-dose. Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02899338.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.