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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

Sponsor
Enterprise Therapeutics Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04488705
Collaborator
(none)
80
Enrollment
1
Location
4
Arms
9.2
Actual Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Design

Study Type:
Interventional
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 :
Aug 13, 2020
Actual Primary Completion Date :
May 19, 2021
Actual Study Completion Date :
May 19, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Number of participants reporting one or more treatment emergent adverse event (TEAE) [Baseline to Week 8]

  2. Number of participants who discontinue due to an adverse event (AE) [Baseline to Week 8]

  3. Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose [Baseline to Week 8]

  4. Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose [Baseline to Week 8]

  5. Number of participants who meet the markedly abnormal criteria for safety laboratory assessments at least once post dose [Baseline to Week 8]

  6. Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose [Baseline to Week 8]

Secondary Outcome Measures

  1. Plasma concentrations of ETD002 [Day 1 pre-dose and at multiple time points (up to 14 days) post final dose]

    Blood levels of ETD002 measured after dosing

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hammersmith Medicines Research London United Kingdom NW10 7EW

Sponsors and Collaborators

  • Enterprise Therapeutics Ltd

Investigators

  • Study Director: David Morris, MD, Enterprise Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enterprise Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT04488705
Other Study ID Numbers:
  • ET-TMEM-01
  • 2020-001080-92
First Posted:
Jul 28, 2020
Last Update Posted:
May 21, 2021
Last Verified:
May 1, 2021
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:
Albuterol

Study Results

No Results Posted as of May 21, 2021