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Trial record 1 of 1 for:    ETD002
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A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04488705
Recruitment Status : Completed
First Posted : July 28, 2020
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Enterprise Therapeutics Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: ETD002 - single dose Drug: Placebo - single dose Drug: ETD002 - 7 day repeat dose Drug: Placebo - 7 day repeat dose Drug: ETD002 - 14 day repeat dose Drug: Placebo - 14 day repeat dose Drug: Salbutamol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 13, 2020
Actual Primary Completion Date : May 19, 2021
Actual Study Completion Date : May 19, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single ascending dose Drug: ETD002 - single dose
Single ascending doses of ETD002

Drug: Placebo - single dose
Single doses of placebo

Experimental: Repeat dose - 7 days Drug: ETD002 - 7 day repeat dose
Twice daily doses of ETD002 for 7 days

Drug: Placebo - 7 day repeat dose
Twice daily doses of Placebo for 7 days

Experimental: Repeat dose - 14 days Drug: ETD002 - 14 day repeat dose
Twice daily doses of ETD002 for 14 days

Drug: Placebo - 14 day repeat dose
Twice daily doses of Placebo for 14 days

Experimental: Repeat dose - 7 days with SABA Drug: ETD002 - 7 day repeat dose
Twice daily doses of ETD002 for 7 days

Drug: Placebo - 7 day repeat dose
Twice daily doses of Placebo for 7 days

Drug: Salbutamol
Twice daily doses of salbutamol for 3 days (Days 5, 6 & 7)




Primary Outcome Measures :
  1. Number of participants reporting one or more treatment emergent adverse event (TEAE) [ Time Frame: Baseline to Week 8 ]
  2. Number of participants who discontinue due to an adverse event (AE) [ Time Frame: Baseline to Week 8 ]
  3. 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 ]
  4. Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose [ Time Frame: Baseline to Week 8 ]
  5. Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose [ Time Frame: Baseline to Week 8 ]
  6. Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose [ Time Frame: Baseline to Week 8 ]

Secondary Outcome Measures :
  1. Plasma concentrations of ETD002 [ Time Frame: Day 1 pre-dose and at multiple time points (up to 14 days) post final dose ]
    Blood levels of ETD002 measured after dosing



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488705


Locations
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United Kingdom
Hammersmith Medicines Research
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
Enterprise Therapeutics Ltd
Investigators
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Study Director: David Morris, MD Enterprise Therapeutics
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Responsible Party: Enterprise Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT04488705    
Other Study ID Numbers: ET-TMEM-01
2020-001080-92 ( EudraCT Number )
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enterprise Therapeutics Ltd:
Cystic fibrosis
Additional relevant MeSH terms:
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Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action