Trial · NCT01316315

Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma

NCT01316315, Phase 1, Phase 2, Completed, Nivalis Therapeutics, Inc.; results first posted 2014-03-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma. Trials, record NCT01316315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01316315

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Trial

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

Title: Study to Evaluate the Bronchoprotective Effects of a Single Dose of N6022 in Patients With Mild Asthma
NCT number: NCT01316315
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 14 participants, actual
Lead sponsor: Nivalis Therapeutics, Inc.
Conditions: Asthma
Interventions: Active, Placebo
First posted: 2011-03-16
Last updated: 2014-05-05
Results first posted: 2014-03-11

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing	24 hours	These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.
Secondary	Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing	8 hours	These assessments will be recorded at various times over the study - Methacholine PC20 at screening, and at 8, 24, 48 hours postdose and Day 7; spirometry assessments will be recorded at screening, at 2, 4, 6, 8, 24, 48 hours postdose and Day 7.
Secondary	To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.	10 Weeks	Adverse event (AE) reporting will begin upon signing of the consent and will continue until end-of-study (follow up phone call Day 28 +/- 2 days after dosing in the second treatment period). Number of patients with an adverse event will be documented and analyzed.
Other	Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing	7 Days

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing	24 hours	Any patient that received a dose of N6022 or placebo.	mg/mL	MEAN
SECONDARY	Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing	8 hours	Any patient that received a dose of N6022 or Placebo	mg/mL	MEAN
SECONDARY	To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.	10 Weeks	Any patient that received a dose of N6022 or placebo	Adverse Events	NUMBER
OTHER_PRE_SPECIFIED	Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing	7 Days	Any patient that received a dose of N6022 or Placebo	mg/mL	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing	N6022	1.48	Standard Error .093	mg/mL
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 24 Hours After Dosing	Placebo	-0.2	Standard Error 0.3	mg/mL
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing	Active	0.3	Standard Error 0.63	mg/mL
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo 8 Hours After Dosing	Placebo	-0.54	Standard Error 0.33	mg/mL
To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.	Active	11		Adverse Events
To Assess the Safety and Tolerability of Single Dose Administration of N6022 in Patients With Mild Asthma.	Placebo	9		Adverse Events
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing	Active	0.74	Standard Error 1.01	mg/mL
Measurement of Change in Methacholine PC20 From Baseline Compared With Placebo After 7 Days of Dosing	Placebo	-0.38	Standard Error .68	mg/mL

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Sequence 1	STARTED	Active	7
Sequence 1	STARTED	Placebo	7
Sequence 1	COMPLETED	Active	7
Sequence 1	COMPLETED	Placebo	7
Sequence 1	NOT COMPLETED	Active	0
Sequence 1	NOT COMPLETED	Placebo	0
Sequence 2	STARTED	Active	7
Sequence 2	STARTED	Placebo	7
Sequence 2	COMPLETED	Active	7
Sequence 2	COMPLETED	Placebo	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events66

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	Events
other	Abdominal Pain Upper	Gastrointestinal disorders	Active	1	14	1
other	Abdominal Pain Upper	Gastrointestinal disorders	Placebo	0	13	0
other	Diarrhea	Gastrointestinal disorders	Active	1	14	1
other	Diarrhea	Gastrointestinal disorders	Placebo	0	13	0
other	Injection Site Hematoma	General disorders	Active	2	14	2
other	Injection Site Hematoma	General disorders	Placebo	0	13	0
other	Blood Creatinine Increased	Injury, poisoning and procedural complications	Active	1	14	1
other	Blood Creatinine Increased	Injury, poisoning and procedural complications	Placebo	0	13	0
other	Blood LDH	Investigations	Active	1	14	1
other	Blood LDH	Investigations	Placebo	1	13	1

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active
Total, all-cause mortality	Placebo
Total, other adverse events	Active	11	14
Total, other adverse events	Placebo	9	13
Total, serious adverse events	Active	0	14
Total, serious adverse events	Placebo	0	13

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29642282	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 comparisons1

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

Comparison
Active vs Placebo: serious adverse events

Source Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01316315

GET https://conductscience.org/api/trials/v1/NCT01316315/events?page=2

API reference For AI assistants