Trial · NCT00867100

Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827

NCT00867100, Phase 1, Completed, Bausch Health Americas, Inc.; results first posted 2019-01-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827. Trials, record NCT00867100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00867100

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 827
NCT number: NCT00867100
Status: Completed
Phases: Phase 1
Enrollment: 84 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: Psoriasis
Interventions: 700 mg IV, 350 mg SC, Placebo, 140 mg SC
First posted: 2009-03-23
Last updated: 2019-01-16
Results first posted: 2019-01-16

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43	Through day 43	Summary of percent change in PASI (Psoriasis Area Severity Index) Scores over time by treatment groups between baseline and day 43, PASI score ranging from (0) no disease to (72) maximal disease.
Primary	Part B: All Treatment Adverse Events Reported for Safety Evaluation	85 days	This primary outcome assesses number of participants iwth any reported adverse events emerging during treatment period.
Primary	Part A: All Treatment Adverse Events Reported for Safety Evaluation	Cohort 1-4 43 days, Cohort 5-8 64 days	This primary outcome assesses the number of participants with any reported adverse events emerging during treatment period.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43	Through day 43	This PASI outcome measure data refers only to Part B subjects with moderate to severe plaque psoriasis.	percentage improvement	MEAN
PRIMARY	Part B: All Treatment Adverse Events Reported for Safety Evaluation	85 days		participants with events	NUMBER
PRIMARY	Part A: All Treatment Adverse Events Reported for Safety Evaluation	Cohort 1-4 43 days, Cohort 5-8 64 days		participants with events	NUMBER

Source ClinicalTrials.gov

Results by group17

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43	Placebo	19.88	Standard Deviation 6.36	percentage improvement
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43	140 mg Sc	17.74	Standard Deviation 15.34	percentage improvement
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43	350 mg Sc	53.57	Standard Deviation 30.45	percentage improvement
Part B: PASI (Psoriasis Area and Severity Index) Score Mean Percentage of Change Through Day 43	700 mg IV	86.04	Standard Deviation 8.70	percentage improvement
Part B: All Treatment Adverse Events Reported for Safety Evaluation	Placebo Part B	4		participants with events
Part B: All Treatment Adverse Events Reported for Safety Evaluation	140 mg Sc Part B	3		participants with events
Part B: All Treatment Adverse Events Reported for Safety Evaluation	350 mg Sc Part B	7		participants with events
Part B: All Treatment Adverse Events Reported for Safety Evaluation	700 mg IV Part B	8		participants with events
Part A: All Treatment Adverse Events Reported for Safety Evaluation	Placebo Part A	14		participants with events
Part A: All Treatment Adverse Events Reported for Safety Evaluation	Cohort 1: 7mg SC Part A	6		participants with events

1 to 10 of 17Source ClinicalTrials.gov

See all 17 results by group

Participant flow39

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Part B	5
Overall Study	STARTED	Cohort 10: 140 mg Sc Part B	5
Overall Study	STARTED	Cohort 11: 350 mg Sc Part B	8
Overall Study	STARTED	Cohort 9: 700 mg IV Part B	8
Overall Study	STARTED	Placebo Part A	14
Overall Study	STARTED	Cohort 1: 7mg SC Part A	6
Overall Study	STARTED	Cohort 2: 21mg SC Part A	7
Overall Study	STARTED	Cohort 3: 21mg IV Part A	3
Overall Study	STARTED	Cohort 4: 70mg SC Part A	6
Overall Study	STARTED	Cohort 5: 210mg SC Part A	6

1 to 10 of 39Source ClinicalTrials.gov

See all 39 participant flow

Adverse events1,222

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Conjunctival Irritation	Eye disorders	Placebo Part B	1	5
other	Conjunctival Irritation	Eye disorders	Cohort 10: 140 mg Sc Part B	0	4
other	Conjunctival Irritation	Eye disorders	Cohort 11: 350 mg Sc Part B	0	8
other	Conjunctival Irritation	Eye disorders	Cohort 9: 700 mg IV Part B	1	8
other	Conjunctival Irritation	Eye disorders	Placebo Part A	0	14
other	Conjunctival Irritation	Eye disorders	Cohort 1: 7mg SC Part A	0	6
other	Conjunctival Irritation	Eye disorders	Cohort 2: 21mg SC Part A	0	6
other	Conjunctival Irritation	Eye disorders	Cohort 3: 21mg IV Part A	0	3
other	Conjunctival Irritation	Eye disorders	Cohort 4: 70mg SC Part A	0	6
other	Conjunctival Irritation	Eye disorders	Cohort 5: 210mg SC Part A	0	6

1 to 10 of 1,222Source ClinicalTrials.gov

See all 1,222 adverse events

Adverse event totals39

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Part B
Total, all-cause mortality	Cohort 10: 140 mg Sc Part B
Total, all-cause mortality	Cohort 11: 350 mg Sc Part B
Total, all-cause mortality	Cohort 9: 700 mg IV Part B
Total, all-cause mortality	Placebo Part A
Total, all-cause mortality	Cohort 1: 7mg SC Part A
Total, all-cause mortality	Cohort 2: 21mg SC Part A
Total, all-cause mortality	Cohort 3: 21mg IV Part A
Total, all-cause mortality	Cohort 4: 70mg SC Part A
Total, all-cause mortality	Cohort 5: 210mg SC Part A

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22622425	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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