NCT05203289

Brief Summary

The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501 100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2022

Typical duration for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

February 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 15, 2024

Completed
Last Updated

March 15, 2024

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

January 13, 2022

Results QC Date

August 18, 2023

Last Update Submit

August 18, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 to 1344 Hours After Dose Administration (AUC0-1344)

    Area under the concentration-time curve of BI 695501 in plasma over the time interval from 0 to 1344 hours after dose administration (AUC0-1344). The presented means are adjusted based on analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment, location of trial medication injection and baseline body weight.

    BI 695501 was measured within 1 hour before and 4, 12, 24, 48, 72, 96, 120, 144, 168, 216, 336, 504, 672, 840, 1008 and 1344 hours after drug administration.

  • Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

    Area under the concentration-time curve of BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The presented means are adjusted based on analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment, location of trial medication injection and baseline body weight.

    BI 695501 was measured within 1 hour before and 4, 12, 24, 48, 72, 96, 120, 144, 168, 216, 336, 504, 672, 840, 1008 and 1344 hours after drug administration.

  • Maximum Measured Concentration of BI 695501 in Plasma (Cmax)

    Maximum measured concentration of BI 695501 in plasma (Cmax). The presented means are adjusted based on analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment, location of trial medication injection and baseline body weight.

    BI 695501 was measured within 1 hour before and 4, 12, 24, 48, 72, 96, 120, 144, 168, 216, 336, 504, 672, 840, 1008 and 1344 hours after drug administration.

Study Arms (2)

BI 695501 40 mg/0.4 mL (T)

EXPERIMENTAL

Participants were subcutaneously injected 40 milligram (mg)/0.4 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Test Treatment (T)).

Drug: BI 695501 - higher concentration

BI 695501 40 mg/0.8 mL (R)

EXPERIMENTAL

Participants were subcutaneously injected 40 milligrams (mg)/0.8 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Reference Treatment (R)).

Drug: BI 695501 - lower concentration

Interventions

BI 695501 - higher concentrationDRUG

BI 695501 - higher concentration

BI 695501 40 mg/0.4 mL (T)
BI 695501 - lower concentrationDRUG

BI 695501 - lower concentration

BI 695501 40 mg/0.8 mL (R)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
  • Age of 18 to 55 years (inclusive).
  • Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive).
  • Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
  • Participants of reproductive potential (childbearing potential1) must be willing and able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year from at least 30 days before administration of the trial medication until 30 days after trial completion.

You may not qualify if:

  • 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 human immunodeficiency virus (HIV), hepatitis B virus (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).
  • Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Miami Research Associates, Inc

Miami, Florida, 33143, United States

Location

QPS MO

Springfield, Missouri, 65802, United States

Location

Related Publications (1)

  • Moschetti V, Buschke S, Bertulis J, Hohl K, McCabe D. Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF). Expert Opin Biol Ther. 2024 Jul;24(7):673-679. doi: 10.1080/14712598.2024.2354902. Epub 2024 May 19.

    PMID: 38739422DERIVED

Related Links

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 24, 2022

Study Start

February 18, 2022

Primary Completion

August 29, 2022

Study Completion

August 29, 2022

Last Updated

March 15, 2024

Results First Posted

March 15, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing

Locations

US(2)