Trial Outcomes & Findings for A Study in Healthy People to Test How 2 Different Formulations of BI 695501 Are Taken up by the Body When Given as an Injection (NCT NCT05203289)
NCT ID: NCT05203289
Last Updated: 2024-03-15
Results Overview
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.
COMPLETED
PHASE1
200 participants
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.
2024-03-15
Participant Flow
This was a 14-week, randomized, single dose, parallel arm, double blind, Phase I trial in healthy male and female subjects aged ≥18 to ≤55 years. The aim of this trial was to evaluate and compare the pharmacokinetics (PK), safety, tolerability, and immunogenicity of the test treatment to the reference treatment administered subcutaneously via prefilled syringe (PFS).
All subjects were screened for eligibility prior to participation in the trials. There was no run-in period and subjects did not have to attend a specialist site. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
BI 695501 40 mg/0.4 mL (T)
Participants were subcutaneously injected 40 milligram (mg)/0.4 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Test Treatment (T)).
|
BI 695501 40 mg/0.8 mL (R)
Participants were subcutaneously injected 40 milligrams (mg)/0.8 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Reference Treatment (R)).
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
|
Overall Study
COMPLETED
|
99
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy People to Test How 2 Different Formulations of BI 695501 Are Taken up by the Body When Given as an Injection
Baseline characteristics by cohort
| Measure |
BI 695501 40 mg/0.4 mL (T)
n=99 Participants
Participants were subcutaneously injected 40 milligram (mg)/0.4 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Test Treatment (T)).
|
BI 695501 40 mg/0.8 mL (R)
n=101 Participants
Participants were subcutaneously injected 40 milligrams (mg)/0.8 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Reference Treatment (R)).
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.4 Years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
37.5 Years
STANDARD_DEVIATION 8.41 • n=7 Participants
|
37.0 Years
STANDARD_DEVIATION 9.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Pharmacokinetic analysis set (PKS): The pharmacokinetic set consisted of all randomized subjects who received the single dose of trial medication, and had at least one evaluable primary pharmacokinetics (PK) parameter, and were without important protocol deviations or violations thought to have a relevant impact on the PK of BI 695501. Only participants with evaluable results for this PK parameter are reported.
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.
Outcome measures
| Measure |
BI 695501 40 mg/0.4 mL (T)
n=93 Participants
Participants were subcutaneously injected 40 milligram (mg)/0.4 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Test Treatment (T)).
|
BI 695501 40 mg/0.8 mL (R)
n=99 Participants
Participants were subcutaneously injected 40 milligrams (mg)/0.8 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Reference Treatment (R)).
|
|---|---|---|
|
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)
|
1415.103 Microgram * hours / milliliter
Geometric Coefficient of Variation 37.600
|
1389.021 Microgram * hours / milliliter
Geometric Coefficient of Variation 37.600
|
PRIMARY outcome
Timeframe: 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.Population: Pharmacokinetic analysis set (PKS): The pharmacokinetic set consisted of all randomized subjects who received the single dose of trial medication, and had at least one evaluable primary pharmacokinetics (PK) parameter, and were without important protocol deviations or violations thought to have a relevant impact on the PK of BI 695501. Only participants with evaluable results for this PK parameter are reported.
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.
Outcome measures
| Measure |
BI 695501 40 mg/0.4 mL (T)
n=93 Participants
Participants were subcutaneously injected 40 milligram (mg)/0.4 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Test Treatment (T)).
|
BI 695501 40 mg/0.8 mL (R)
n=99 Participants
Participants were subcutaneously injected 40 milligrams (mg)/0.8 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Reference Treatment (R)).
|
|---|---|---|
|
Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
1518.311 Microgram * hours / milliliter
Geometric Coefficient of Variation 44.690
|
1440.860 Microgram * hours / milliliter
Geometric Coefficient of Variation 44.690
|
PRIMARY outcome
Timeframe: 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.Population: Pharmacokinetic analysis set (PKS): The pharmacokinetic set consisted of all randomized subjects who received the single dose of trial medication, and had at least one evaluable primary pharmacokinetics (PK) parameter, and were without important protocol deviations or violations thought to have a relevant impact on the PK of BI 695501. Only participants with evaluable results for this PK parameter are reported.
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.
Outcome measures
| Measure |
BI 695501 40 mg/0.4 mL (T)
n=98 Participants
Participants were subcutaneously injected 40 milligram (mg)/0.4 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Test Treatment (T)).
|
BI 695501 40 mg/0.8 mL (R)
n=101 Participants
Participants were subcutaneously injected 40 milligrams (mg)/0.8 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Reference Treatment (R)).
|
|---|---|---|
|
Maximum Measured Concentration of BI 695501 in Plasma (Cmax)
|
2.811 Microgram / milliliter
Geometric Coefficient of Variation 34.215
|
3.079 Microgram / milliliter
Geometric Coefficient of Variation 34.215
|
Adverse Events
BI 695501 40 mg/0.4 mL (T)
BI 695501 40 mg/0.8 mL (R)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 695501 40 mg/0.4 mL (T)
n=99 participants at risk
Participants were subcutaneously injected 40 milligram (mg)/0.4 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Test Treatment (T)).
|
BI 695501 40 mg/0.8 mL (R)
n=101 participants at risk
Participants were subcutaneously injected 40 milligrams (mg)/0.8 milliliter (mL) of BI 695501 solution for injection in prefilled syringe (PFS) (Reference Treatment (R)).
|
|---|---|---|
|
General disorders
Injection site erythema
|
1.0%
1/99 • From first drug administration until the end of study (e.o.s.) examination. That means up to 70 days.
Safety analysis set (SAF): The SAF included all subjects who were randomized and treated with study drug and will be analyzed according to treatment received.
|
7.9%
8/101 • From first drug administration until the end of study (e.o.s.) examination. That means up to 70 days.
Safety analysis set (SAF): The SAF included all subjects who were randomized and treated with study drug and will be analyzed according to treatment received.
|
|
Nervous system disorders
Headache
|
5.1%
5/99 • From first drug administration until the end of study (e.o.s.) examination. That means up to 70 days.
Safety analysis set (SAF): The SAF included all subjects who were randomized and treated with study drug and will be analyzed according to treatment received.
|
5.0%
5/101 • From first drug administration until the end of study (e.o.s.) examination. That means up to 70 days.
Safety analysis set (SAF): The SAF included all subjects who were randomized and treated with study drug and will be analyzed according to treatment received.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER