Study to Investigate the Efficacy and Safety of SC0023, i... | NCT07003347

Studies
Study to Investigate the Efficacy and Safety of SC0023, in Adults With Refractory or Unexplained Chronic Cough

NCT07003347

Sponsor

Kholood Altassan

Status

Completed

Last Update Posted

Jan 21, 2026Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Chronic Cough

Interventions

oral spray of MgCl2
Saline

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2024Actual

Primary Completion Date

Jul 30, 2025Actual

Completion Date

Aug 30, 2025Actual

First Submitted Date

May 14, 2025

First Submission Date that Met QC Criteria

May 25, 2025

First Posted Date

Jun 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2026

Last Update Posted Date

Jan 21, 2026Actual

Description Module

Brief Summary

This is a randomized, double-blind, placebo controlled cross-over study to investigate the efficacy and safety of SC0023 (an oral spray of magnesium based alkaline hypertonic divalent salt) in adults with refractory or unexplained chronic cough over 14 days.

Approximately 20 participants being enrolled and randomized into the study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Label	Type	Description	Intervention Names
oral spray of MgCl2	Experimental		Device: oral spray of MgCl2
Placebo	Placebo Comparator		Device: Saline

Name	Type	Description	Arm Group Labels	Other Names
oral spray of MgCl2	Device	Magnesium Salt Oral Spray Device	oral spray of MgCl2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in 24 hour cough frequency		From Baseline to Day 56

Secondary Outcomes

Measure	Description	Time Frame
Percentage of participants with a reduction from baseline in the 24-hour cough frequency by ≥ 30%, 50% and 70% compared with placebo. Assessed using HYFE digital cough monitor.		From Baseline to Day 56
Change in cough severity using a visual analogue scale (100 mm visual scale)

Other Outcomes

Measure	Description	Time Frame
Change in exhaled breath condensate (EBC) pH (using an EBC monitor) relative to baseline and placebo over 14 days		14 Days of Dosing
This study will characterize cough counts over the duration of the study and explore the effect of air quality (where adopted) on cough count and the impact of SC0023 on this parameters.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females between 18-80 years
Capable of giving signed informed consent
Diagnosed with RCC (including unexplained chronic cough) for at least 6 months and at least 4 coughs per hour on average during awake hours at Screening.
Score ≥ 40 mm on cough severity VAS at screening.
Normal FEV/FVC
Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose.

Exclusion Criteria:

Current smoker/vaper (all forms of smoking and inhaled substances, including, cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history.
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma.
Respiratory tract infection within 4 weeks before screening.
History of malignancy in the last 5 years.
History of alcohol or drug abuse within the last 3 years.
Opioid use in last 7 days of screening.
History of a positive serologic test for, hepatitis B virus surface antigen, or hepatitis C virus.
Previous participation in clinical trial in last 30 days or 6-half lives of test drug activity.
Use of prohibited medications anti-tussive therapy, gabapentin, pregabalin, baclofen, tricyclics, systemic corticosteroids, ACE inhibitors, beta blockers.
Use of dietary supplements containing magnesium for the duration of the study.
History of myocardial infarction or other cardiac disorders.
History of any clinically significant or psychiatric condition that in the eyes of the Investigator or designee would not be suitable for this study. Or if in the eyes of the Investigator or designee may prove noncompliant to study procedures.
Spouses or other family members with a chronic cough in household or
Living and working in an excessively loud workplace (e.g. building site)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003371	Cough
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory