HealthyPhase 1NCT04488705
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects
A Phase 1 study testing ETD002 - single dose, ETD002 - 7 day repeat dose and ETD002 - 14 day repeat dose in people with Healthy, run by Enterprise Therapeutics Ltd at 1 site in United Kingdom.
Trial summary
This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled ETD002 in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ETD002 - single dose, ETD002 - 7 day repeat dose and ETD002 - 14 day repeat dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Aug 2020to 19 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males \& females using suitable methods of contraception or females of non-childbearing potential
- Consent to study participation
- Body weight ≥ 50 kg and body mass index within the range 19 - 30 kg/m2
- Vital signs assessments within normal ranges
- Healthy as determined following physical examination at screening visit
- Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value
Who cannot join
- Acute or chronic illness detected at screening visit
- Respiratory tract infection within 4 weeks of the screening visit
- Use of prescription or OTC medication within 14 days of the screening visit
- History of regular alcohol consumption over recommended limits within 6 months of the study, or history/evidence of alcohol or drug abuse
- Smoking or use of tobacco products within 6 months of screening
- Abnormal blood/urine laboratory screening test results
- Current, or history of, allergy that may be contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First in Human, Randomised, Double Blind, Placebo-controlled, Three-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD & MAD) of Inhaled ETD002 in Healthy Male and Female Subjects
This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled ETD002 in healthy male and female subjects.
- Conditions
- Healthy
- Being tested
- ETD002 - single dose, Placebo - single dose, ETD002 - 7 day repeat dose, Placebo - 7 day repeat dose, ETD002 - 14 day repeat dose
- Keywords
- Cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETD002 - single doseDrug
Single ascending doses of ETD002
Placebo - single doseDrug
Single doses of placebo
ETD002 - 7 day repeat doseDrug
Twice daily doses of ETD002 for 7 days
Placebo - 7 day repeat doseDrug
Twice daily doses of Placebo for 7 days
ETD002 - 14 day repeat doseDrug
Twice daily doses of ETD002 for 14 days
Placebo - 14 day repeat doseDrug
Twice daily doses of Placebo for 14 days
SalbutamolDrug
Twice daily doses of salbutamol for 3 days (Days 5, 6 \& 7)
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose | Experimental | Not described Receives: Drug: ETD002 - single dose; Drug: Placebo - single dose |
| Repeat dose - 7 days | Experimental | Not described Receives: Drug: ETD002 - 7 day repeat dose; Drug: Placebo - 7 day repeat dose |
| Repeat dose - 14 days | Experimental | Not described Receives: Drug: ETD002 - 14 day repeat dose; Drug: Placebo - 14 day repeat dose |
| Repeat dose - 7 days with SABA | Experimental | Not described Receives: Drug: ETD002 - 7 day repeat dose; Drug: Placebo - 7 day repeat dose; Drug: Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting one or more treatment emergent adverse event (TEAE)
Measured: Baseline to Week 8
Number of participants who discontinue due to an adverse event (AE)
Measured: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
Measured: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
Measured: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose
Measured: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose
Measured: Baseline to Week 8
Secondary outcomes (1)
Plasma concentrations of ETD002
Blood levels of ETD002 measured after dosing
Measured: Day 1 pre-dose and at multiple time points (up to 14 days) post final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start13 Aug 2020
- Primary completion19 May 2021
- Study completion19 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enterprise Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Morris, MD, Study director, Enterprise Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488705
- Sponsor's protocol ID
- ET-TMEM-01
- Other IDs
- 2020-001080-92
- Status last verified
- May 2021
- First submitted
- 23 Jul 2020
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Miller P, Repplinger D, Zhu R, Chen Y, Lewin-Koh N, Morris D, Russell P, She G, Singh N, White R, Wilkes D, Chen H, Galanter J. Randomized, phase I studies to evaluate the safety, tolerability, and pharmacokinetics of an inhaled, TMEM16A potentiator, GDC-6988, in healthy subjects. Ther Adv Respir Dis. 2025 Jan-Dec;19:17534666251393346. doi: 10.1177/17534666251393346. Epub 2025 Nov 29.
PubMed 41318901
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human, Randomised, Double Blind, Placebo-controlled, Three-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD & MAD) of Inhaled ETD002 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT04488705
- Acronym / sponsor ID
- ET-TMEM-01
- Conditions
- Healthy
- Keywords
- Cystic fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Enterprise Therapeutics LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled ETD002 in healthy male and female subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose | Experimental | Drug: ETD002 - single dose, Drug: Placebo - single dose |
| Repeat dose - 7 days | Experimental | Drug: ETD002 - 7 day repeat dose, Drug: Placebo - 7 day repeat dose |
| Repeat dose - 14 days | Experimental | Drug: ETD002 - 14 day repeat dose, Drug: Placebo - 14 day repeat dose |
| Repeat dose - 7 days with SABA | Experimental | Drug: ETD002 - 7 day repeat dose, Drug: Placebo - 7 day repeat dose, Drug: Salbutamol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males \& females using suitable methods of contraception or females of non-childbearing potential
- Consent to study participation
- Body weight ≥ 50 kg and body mass index within the range 19 - 30 kg/m2
- Vital signs assessments within normal ranges
- Healthy as determined following physical examination at screening visit
Key exclusion criteria (7 listed)
- Acute or chronic illness detected at screening visit
- Respiratory tract infection within 4 weeks of the screening visit
- Use of prescription or OTC medication within 14 days of the screening visit
- History of regular alcohol consumption over recommended limits within 6 months of the study, or history/evidence of alcohol or drug abuse
- Smoking or use of tobacco products within 6 months of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETD002 - single doseSingle ascending doses of ETD002 | Drug | Single ascending dose |
| Placebo - single doseSingle doses of placebo | Drug | Single ascending dose |
| ETD002 - 7 day repeat doseTwice daily doses of ETD002 for 7 days | Drug | Repeat dose - 7 days, Repeat dose - 7 days with SABA |
| Placebo - 7 day repeat doseTwice daily doses of Placebo for 7 days | Drug | Repeat dose - 7 days, Repeat dose - 7 days with SABA |
| ETD002 - 14 day repeat doseTwice daily doses of ETD002 for 14 days | Drug | Repeat dose - 14 days |
| Placebo - 14 day repeat doseTwice daily doses of Placebo for 14 days | Drug | Repeat dose - 14 days |
| SalbutamolTwice daily doses of salbutamol for 3 days (Days 5, 6 \& 7) | Drug | Repeat dose - 7 days with SABA |
Primary outcome
Number of participants reporting one or more treatment emergent adverse event (TEAE)
Time frame: Baseline to Week 8
Number of participants who discontinue due to an adverse event (AE)
Time frame: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
Time frame: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
Time frame: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose
Time frame: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose
Time frame: Baseline to Week 8
1 secondary outcome
Plasma concentrations of ETD002
Time frame: Day 1 pre-dose and at multiple time points (up to 14 days) post final dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Derived from this study: PubMed 41318901Miller P, Repplinger D, Zhu R, Chen Y, Lewin-Koh N, Morris D, Russell P, She G, Singh N, White R, Wilkes D, Chen H, Galanter J. Randomized, phase I studies to evaluate the safety, tolerability, and pharmacokinetics of an inhaled, TMEM16A potentiator, GDC-6988, in healthy subjects. Ther Adv Respir Dis. 2025 Jan-Dec;19:17534666251393346. doi: 10.1177/17534666251393346. Epub 2025 Nov 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Morris, MD study director
Enterprise Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ETD002 - single dose, ETD002 - 7 day repeat dose and ETD002 - 14 day repeat dose in people with Healthy, run by Enterprise Therapeutics Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reporting one or more treatment emergent adverse event (TEAE) (time frame: Baseline to Week 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04488705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.