Trial Outcomes & Findings for Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma (NCT NCT00410280)

Last Updated: 2014-11-18

Results Overview

Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (\>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours at Screening was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)

Results posted on

2014-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	IMA-638 2mg/kg IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Overall Study STARTED	14	13
Overall Study COMPLETED	14	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating the Effects of IMA-638 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.	Total n=27 Participants Total of all reporting groups
Age, Continuous	26.14 years STANDARD_DEVIATION 6.25 • n=113 Participants	32.31 years STANDARD_DEVIATION 11.66 • n=163 Participants	29.11 years STANDARD_DEVIATION 9.60 • n=160 Participants
Sex: Female, Male Female	7 Participants n=113 Participants	8 Participants n=163 Participants	15 Participants n=160 Participants
Sex: Female, Male Male	7 Participants n=113 Participants	5 Participants n=163 Participants	12 Participants n=160 Participants

PRIMARY outcome

Timeframe: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14)

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening	27.19 percent drop Standard Deviation 9.75	20.47 percent drop Standard Deviation 8.12

PRIMARY outcome

Timeframe: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 14

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article.

Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (\>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 14 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 14	12.84 percent drop Standard Deviation 10.29	19.28 percent drop Standard Deviation 10.69

PRIMARY outcome

Timeframe: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Day 35

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article.

Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of more than or equal to (\>=) 15 percent (%) at 3 to 7 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 3 to 7 hours on Day 35 was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Day 35	11.32 percent drop Standard Deviation 9.39	15.56 percent drop Standard Deviation 10.45

SECONDARY outcome

Timeframe: Pre-allergen baseline, 3, 4, 5, 6, 7 hours post-allergen inhalation at Screening (Day -14), Day 14, 35

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article.

Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. LAR was characterized by a fall in FEV1 of \>=15% at 3 to 7 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 3 to 7 hours was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR) Screening	57.57 Percent drop*hour Standard Deviation 24.26	55.64 Percent drop*hour Standard Deviation 27.78
Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR) Day 35	21.94 Percent drop*hour Standard Deviation 21.27	39.11 Percent drop*hour Standard Deviation 37.46
Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 3 to 7 Hours for Late-Phase Asthma Response (LAR) Day 14	25.48 Percent drop*hour Standard Deviation 29.49	49.28 Percent drop*hour Standard Deviation 32.66

SECONDARY outcome

Timeframe: Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article.

Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 \>=20% at 0 to 3 hours post-allergen inhalation. Maximum drop in FEV1 relative to the pre-allergen baseline FEV1 between 0 to 3 hours was reported. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35 Screening	33.23 percent drop Standard Deviation 6.26	34.40 percent drop Standard Deviation 8.51
Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35 Day 14	20.40 percent drop Standard Deviation 14.98	30.15 percent drop Standard Deviation 13.57
Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Early-Phase Asthma Response (EAR) at Screening, Day 14 and 35 Day 35	22.76 percent drop Standard Deviation 13.51	26.82 percent drop Standard Deviation 13.56

SECONDARY outcome

Timeframe: Pre-allergen baseline, 10, 20, 30, 45, 60, 90, 120, 180 minutes post-allergen inhalation Screening, Day 14, 35

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article.

Allergen inhalation test was performed at Screening, Day 14 and 35 to elicit airway responses similar to those that follow natural allergen exposure. FEV1 was the maximal volume of air exhaled in 1 second of a forced expiration from a position of full inspiration. EAR was characterized by a fall in FEV1 \>=20% at 0 to 3 hours post-allergen inhalation. Area under the percent drop in FEV1 relative to the pre-allergen baseline FEV1 from 0 to 3 hours at each visit was computed using the linear trapezoidal rule. Pre-allergen baseline FEV1 was performed in triplicate using spirometry and the best of the 3 values was selected.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR) Day 35	25.75 percent drop*hour Standard Deviation 18.21	38.94 percent drop*hour Standard Deviation 24.42
Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR) Screening	45.37 percent drop*hour Standard Deviation 15.03	50.39 percent drop*hour Standard Deviation 24.09
Area Under the Percent Drop in Forced Expiratory Volume in 1 Second Curve (AUC FEV1) From Time 0 to 3 Hours for Early-Phase Asthma Response (EAR) Day 14	21.51 percent drop*hour Standard Deviation 23.20	40.56 percent drop*hour Standard Deviation 26.62

SECONDARY outcome

Timeframe: Day -15, -13 for Screening (Day -14) challenge; Day 13, 15 for Day 14 challenge; Day 34, 36 for Day 35 challenge

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article.

Methacholine inhalation test was performed to determine airway hyper-reactivity using provocative concentration 20 (PC20). PC20 was the lowest concentration of methacholine at which participant had 20% decrease from baseline in FEV1. Pre-allergen challenge methacholine inhalation test was performed 1 day prior to the allergen challenge and post-allergen challenge methacholine inhalation test was performed 1 day after to the allergen challenge (that is, pre- and post-allergen methacholine inhalation test was conducted on Day -15 and -13 for Screening allergen challenge, Day 13 and 15 for Day 14 allergen challenge and Day 34 and 36 for Day 35 allergen challenge, respectively). For each methacholine inhalation test, baseline FEV1 was defined as the lowest value among the triplicate readings taken after administration of the diluent (saline administration). Difference between post-allergen challenge and pre-allergen challenge was expressed as log2 (post-allergen PC20 - pre-allergen PC20).

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Change From Pre-allergen Challenge in Provocative Concentration of Methacholine Causing a 20% Fall in FEV1 (PC20) to Post-allergen Challenge For Screening, Day 14 and 35 Challenge Day 14	-0.63 Log2 milligram/milliliter (log2 mg/mL) Standard Deviation 1.20	-0.63 Log2 milligram/milliliter (log2 mg/mL) Standard Deviation 1.28
Change From Pre-allergen Challenge in Provocative Concentration of Methacholine Causing a 20% Fall in FEV1 (PC20) to Post-allergen Challenge For Screening, Day 14 and 35 Challenge Screening	-1.37 Log2 milligram/milliliter (log2 mg/mL) Standard Deviation 0.74	-1.47 Log2 milligram/milliliter (log2 mg/mL) Standard Deviation 1.72
Change From Pre-allergen Challenge in Provocative Concentration of Methacholine Causing a 20% Fall in FEV1 (PC20) to Post-allergen Challenge For Screening, Day 14 and 35 Challenge Day 35	-0.71 Log2 milligram/milliliter (log2 mg/mL) Standard Deviation 0.97	-0.43 Log2 milligram/milliliter (log2 mg/mL) Standard Deviation 0.72

SECONDARY outcome

Timeframe: Baseline, Day 14, 35

Population: Data was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.

The collected sputum was planned to be analyzed for epithelial cells, eosinophils, lymphocytes, neutrophils, metachromatic cells, or macrophages counts. Sputum induction was to be performed after each methacholine challenge and at 7 hours after each allergen inhalation challenge.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.

The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge within a given challenge triad (planned on day 13 and 34). The challenge triad included pre-allergen methacholine inhalation challenge, allergen inhalation challenge, and post-allergen methacholine inhalation challenge. Results are reported for total IgE count.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Allergen Specific and Total Immunoglobulin E (IgE) Count at Baseline	259.7 kilo unit/liter (kU/L) Standard Deviation 395.8	179.8 kilo unit/liter (kU/L) Standard Deviation 204.7

SECONDARY outcome

Timeframe: Baseline, Day 13, 34, 56, 112, 168

Population: ITT population. Here, "n" signifies participants evaluated for this measure at the specified time point for each arm. Allergen-specific IgE was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.

The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34). Results are reported for total IgE count.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168 Change at Day 13 (n=14, 13)	29.1 kU/L Standard Error 23.1	-4.4 kU/L Standard Error 10.9
Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168 Change at Day 34 (n=14, 13)	37.4 kU/L Standard Error 43.9	1.5 kU/L Standard Error 8.4
Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168 Change at Day 56 (n=13, 13)	4.2 kU/L Standard Error 8.6	-14.2 kU/L Standard Error 13.8
Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168 Change at Day 112 (n=13, 13)	-9.2 kU/L Standard Error 21.9	-32.0 kU/L Standard Error 16.3
Change From Baseline in Allergen Specific and Total Immunoglobulin E (IgE) Count at Day 13, 34, 56, 112 and 168 Change at Day 168 (n=14, 13)	-40.0 kU/L Standard Error 55.6	-12.2 kU/L Standard Error 31.6

SECONDARY outcome

Timeframe: Baseline

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article.

The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on day 13 and 34).

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Total Blood Eosinophil Counts at Baseline	0.276 10^9 cells/Liter Standard Deviation 0.140	0.315 10^9 cells/Liter Standard Deviation 0.469

SECONDARY outcome

Timeframe: Baseline, Day 8, 13, 21, 34, 56, 84, 168

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article. Here, "n" signifies participants evaluated for this measure at the specified time point for each arm.

The baseline for the outcome measure was defined as the last post-dose measurement obtained prior to the allergen challenge (planned on Day 13 and 34).

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168 Change at Day 8 (n=14,13)	0.051 10^9 cells/Liter Standard Error 0.039	-0.112 10^9 cells/Liter Standard Error 0.090
Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168 Change at Day 13 (n=14, 13)	0.089 10^9 cells/Liter Standard Error 0.044	-0.056 10^9 cells/Liter Standard Error 0.091
Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168 Change at Day 56 (n=12, 13)	0.023 10^9 cells/Liter Standard Error 0.051	-0.128 10^9 cells/Liter Standard Error 0.072
Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168 Change at Day 84 (n=0, 1)	NA 10^9 cells/Liter Standard Error NA Data was not presented because none of the participants were evaluable at Day 84 for this reporting arm.	0.030 10^9 cells/Liter Standard Error NA Standard Error could not been estimated as single participant was evaluable for this reporting arm.
Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168 Change at Day 168 (n=14, 13)	-0.007 10^9 cells/Liter Standard Error 0.051	-0.141 10^9 cells/Liter Standard Error 0.138
Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168 Change at Day 21(n=14, 13)	0.060 10^9 cells/Liter Standard Error 0.062	-0.008 10^9 cells/Liter Standard Error 0.035
Change From Baseline in Total Blood Eosinophil Counts at Day 8, 13, 21, 34, 56, 84 and 168 Change at Day 34 (n=14, 13)	0.026 10^9 cells/Liter Standard Error 0.042	-0.022 10^9 cells/Liter Standard Error 0.039

SECONDARY outcome

Timeframe: Screening, baseline, Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168

Population: Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112

Population: Data for this outcome measure was not analyzed because the study was stopped early after interim analysis and only safety and key efficacy analyses were performed.

Sputum induction was performed after each methacholine challenge and at hour 7 after each allergen inhalation challenge. The baseline for this outcome measure was defined as the last value prior to dosing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening (Day-13, -14, -15), Day 1, 13, 14, 15, 34, 35, 36, 112

Population: Data for this outcome measure w as not analyzed because the study w as stopped early after interim analysis and only safety and key efficacy analyses w ere performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168

Population: Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Maximum Observed Serum Concentration (Cmax) for IMA-638	30.5 microgram/milliliter(mcg/mL) Standard Deviation 6.4	—

SECONDARY outcome

Timeframe: Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168

Population: Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Time to Reach Maximum Observed Serum Concentration (Tmax) for IMA-638	8.5 days Standard Deviation 4.4	—

SECONDARY outcome

Timeframe: Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168

Population: Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.

Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-t).

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] for IMA-638	32259.13 microgramhour/milliliter (mcghr/mL) Standard Deviation 6255.88	—

SECONDARY outcome

Timeframe: Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168

Population: Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for IMA-638	32609.32 mcg*hr/mL Standard Deviation 6369.46	—

SECONDARY outcome

Timeframe: Day 1, 8, 14, 21, 35, 56, 84, 112, 140, 168

Population: Evaluable population included all randomized participants who received at least 1 dose administration of the test article and had evaluable pharmacokinetic data.

Serum decay half-life is the time measured for the serum concentration to decrease by one half.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Serum Decay Half-Life (t1/2) for IMA-638	25.1 days Standard Deviation 4.7	—

SECONDARY outcome

Timeframe: Baseline up to Day 168

Population: ITT population included all randomized participants who received at least 1 dose administration of the test article.

Outcome measures

Outcome measures
Measure	IMA-638 2mg/kg n=14 Participants IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 Participants Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Number of Participants With Antibodies to IMA-638	0 participants	0 participants

Adverse Events

IMA-638 2mg/kg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IMA-638 2mg/kg n=14 participants at risk IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.	Placebo n=13 participants at risk Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
Blood and lymphatic system disorders Lymphadenopathy	7.1% 1/14	0.00% 0/13
Eye disorders Conjunctivitis	7.1% 1/14	0.00% 0/13
Gastrointestinal disorders Abdominal pain	0.00% 0/14	7.7% 1/13
Gastrointestinal disorders Haematochezia	0.00% 0/14	7.7% 1/13
Gastrointestinal disorders Nausea	7.1% 1/14	0.00% 0/13
General disorders Injection site bruising	0.00% 0/14	7.7% 1/13
General disorders Injection site erythema	7.1% 1/14	0.00% 0/13
General disorders Injection site paresthesia	0.00% 0/14	7.7% 1/13
General disorders Injection site swelling	7.1% 1/14	7.7% 1/13
Infections and infestations Gastroenteritis	0.00% 0/14	15.4% 2/13
Infections and infestations Nasopharyngitis	14.3% 2/14	7.7% 1/13
Infections and infestations Pharyngitis	0.00% 0/14	7.7% 1/13
Infections and infestations Sinusitis	0.00% 0/14	7.7% 1/13
Infections and infestations Urinary tract infection	0.00% 0/14	15.4% 2/13
Infections and infestations Viral upper respiratory tract infection	7.1% 1/14	7.7% 1/13
Injury, poisoning and procedural complications Neck injury	0.00% 0/14	7.7% 1/13
Injury, poisoning and procedural complications Procedural dizziness	7.1% 1/14	0.00% 0/13
Injury, poisoning and procedural complications Procedural pain	7.1% 1/14	0.00% 0/13
Investigations Lymphocyte count decreased	0.00% 0/14	7.7% 1/13
Investigations White blood cell count decreased	0.00% 0/14	7.7% 1/13
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14	0.00% 0/13
Nervous system disorders Headache	0.00% 0/14	7.7% 1/13
Nervous system disorders Syncope	7.1% 1/14	0.00% 0/13
Nervous system disorders Syncope vasovagal	7.1% 1/14	0.00% 0/13
Respiratory, thoracic and mediastinal disorders Asthma	14.3% 2/14	0.00% 0/13
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	21.4% 3/14	15.4% 2/13
Skin and subcutaneous tissue disorders Rash	0.00% 0/14	7.7% 1/13

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER