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An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03229252
Acronym
(HOPE-1)
Enrollment
91
Registered
2017-07-25
Start date
2017-08-01
Completion date
2019-06-20
Last updated
2019-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.

Interventions

DRUGPlacebo Inhalation Solution

Normal Saline Inhalation Solution

DRUGSPX-101

SPX-101 Inhalation Solution

Sponsors

Spyryx Biosciences, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-Blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Confirmed diagnosis of cystic fibrosis * ppFEV1 (percent predicted FEV1) between 50.0% and 80.0% * Stable CF Lung Disease * Males and non-pregnant, non-lactating females

Exclusion criteria

* Significant unstable co-morbidities within 28 days of screening * Has received an investigational drug within 28 days of screening

Design outcomes

Primary

MeasureTime frame
Change in Percent Predicted FEV1Baseline and Day 28

Secondary

MeasureTime frameDescription
Number of Participants With Adverse EventsDay 1 through Day 28—
Change From Baseline Through Day 28 in Clinical Laboratory TestsDay 1 through Day 28Chemistry, Hematology, Urinalysis

Countries

Canada, France, Italy, Portugal, United Kingdom

Participant flow

Participants by arm

ArmCount
Placebo
Placebo Inhalation solution twice daily for 28 days. Placebo Inhalation Solution: Normal Saline Inhalation Solution
31
SPX-101 Low Dose (60mg BID)
Inhalation solution twice daily for 28 days. SPX-101: SPX-101 Inhalation Solution
15
SPX-101 High Dose (120mg BID)
Inhalation solution twice daily for 28 days. SPX-101: SPX-101 Inhalation Solution
45
Total91

Baseline characteristics

CharacteristicSPX-101 Low Dose (60mg BID)PlaceboSPX-101 High Dose (120mg BID)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
15 Participants31 Participants45 Participants91 Participants
Age, Continuous33.7 years
STANDARD_DEVIATION 8.62
30.8 years
STANDARD_DEVIATION 7.82
31.9 years
STANDARD_DEVIATION 8.49
31.8 years
STANDARD_DEVIATION 8.25
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants2 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants29 Participants43 Participants86 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants2 Participants0 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
3 Participants3 Participants1 Participants7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
12 Participants26 Participants44 Participants82 Participants
Region of Enrollment
Canada
5 participants3 participants8 participants16 participants
Region of Enrollment
France
2 participants12 participants13 participants27 participants
Region of Enrollment
Italy
0 participants1 participants3 participants4 participants
Region of Enrollment
Portugal
1 participants1 participants6 participants8 participants
Region of Enrollment
United Kingdom
7 participants14 participants15 participants36 participants
Sex: Female, Male
Female
4 Participants11 Participants22 Participants37 Participants
Sex: Female, Male
Male
11 Participants20 Participants23 Participants54 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 150 / 45
other
Total, other adverse events
20 / 3110 / 1529 / 45
serious
Total, serious adverse events
1 / 310 / 153 / 45

Outcome results

Primary

Change in Percent Predicted FEV1

Time frame: Baseline and Day 28

ArmMeasureValue (MEAN)Dispersion
PlaceboChange in Percent Predicted FEV11.633 change from baseline in ppFEV1Standard Deviation 6.3302
SPX-101 Low Dose (60mg BID)Change in Percent Predicted FEV10.800 change from baseline in ppFEV1Standard Deviation 6.5049
SPX-101 High Dose (120mg BID)Change in Percent Predicted FEV10.890 change from baseline in ppFEV1Standard Deviation 6.7061
Secondary

Change From Baseline Through Day 28 in Clinical Laboratory Tests

Chemistry, Hematology, Urinalysis

Time frame: Day 1 through Day 28

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PlaceboChange From Baseline Through Day 28 in Clinical Laboratory TestsBlood Electrolytes (Potassium) High0 Participants
PlaceboChange From Baseline Through Day 28 in Clinical Laboratory TestsBlood Electrolytes (Potassium) Low0 Participants
PlaceboChange From Baseline Through Day 28 in Clinical Laboratory TestsBlood Electrolytes (Potassium) Normal29 Participants
SPX-101 Low Dose (60mg BID)Change From Baseline Through Day 28 in Clinical Laboratory TestsBlood Electrolytes (Potassium) High1 Participants
SPX-101 Low Dose (60mg BID)Change From Baseline Through Day 28 in Clinical Laboratory TestsBlood Electrolytes (Potassium) Low0 Participants
SPX-101 Low Dose (60mg BID)Change From Baseline Through Day 28 in Clinical Laboratory TestsBlood Electrolytes (Potassium) Normal13 Participants
SPX-101 High Dose (120mg BID)Change From Baseline Through Day 28 in Clinical Laboratory TestsBlood Electrolytes (Potassium) High0 Participants
SPX-101 High Dose (120mg BID)Change From Baseline Through Day 28 in Clinical Laboratory TestsBlood Electrolytes (Potassium) Low0 Participants
SPX-101 High Dose (120mg BID)Change From Baseline Through Day 28 in Clinical Laboratory TestsBlood Electrolytes (Potassium) Normal40 Participants
Secondary

Number of Participants With Adverse Events

Time frame: Day 1 through Day 28

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PlaceboNumber of Participants With Adverse Events20 Participants
SPX-101 Low Dose (60mg BID)Number of Participants With Adverse Events11 Participants
SPX-101 High Dose (120mg BID)Number of Participants With Adverse Events30 Participants

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026