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A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ETD001 single dose
Placebo single dose
ETD001 multiple twice daily doses
Placebo multiple twice daily doses
ETD001 multiple once daily doses
Placebo multiple once daily doses
Sponsored by
Enterprise Therapeutics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females using suitable methods of contraception, or females of non-childbearing potential
  • Consent to study participation
  • Body weight ≥ 50 kg and body mass index 19 - 30 kg/m2
  • Vital sign assessments within the normal ranges
  • Healthy as determined following physical and laboratory examinations at screening visit
  • Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value

Exclusion Criteria:

  • Acute or chronic illness detected at the screening visit
  • Respiratory tract infection within 4 weeks of the screening visit
  • Use of prescribed or OTC medication within 14 days of the screening visit
  • History of regular alcohol use over the recommended limits within 6 months of screening, or history/evidence of alcohol or drug abuse
  • Smoker or use of tobacco products within 6 months of screening
  • Abnormal blood or urine laboratory test results at screening
  • Recent participation (within 3 months) in another clinical trial
  • Current, or history of, allergy that may be contraindicated

Sites / Locations

  • Hammersmith Medicines Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Single ascending dose

Multiple ascending dose (7 days)

Multiple ascending dose (14 days)

Arm Description

Single dose of inhaled ETD001/placebo on one occasion

Daily doses of ETD001/placebo for 7 consecutive days

Daily doses of ETD001/placebo for 14 consecutive days

Outcomes

Primary Outcome Measures

Number of participants reporting one or more treatment emergent adverse event (TEAE)
Number of participants who discontinue due to an adverse event (AE)
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
Number of participants who meet the markedly abnormal criteria for laboratory assessments at least once post dose
Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose

Secondary Outcome Measures

Plasma concentrations of ETD001
Blood levels of ETD001 measured after dosing

Full Information

First Posted
June 10, 2021
Last Updated
March 23, 2022
Sponsor
Enterprise Therapeutics Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04926701
Brief Title
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects
Official Title
A First in Human Randomised, Double Blind, Placebo-controlled, Two-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD and MAD) of Inhaled ETD001 in Healthy Male and Female Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enterprise Therapeutics Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled ETD001in healthy male and female subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single ascending dose
Arm Type
Experimental
Arm Description
Single dose of inhaled ETD001/placebo on one occasion
Arm Title
Multiple ascending dose (7 days)
Arm Type
Experimental
Arm Description
Daily doses of ETD001/placebo for 7 consecutive days
Arm Title
Multiple ascending dose (14 days)
Arm Type
Experimental
Arm Description
Daily doses of ETD001/placebo for 14 consecutive days
Intervention Type
Drug
Intervention Name(s)
ETD001 single dose
Intervention Description
Single ascending doses of inhaled ETD001
Intervention Type
Drug
Intervention Name(s)
Placebo single dose
Intervention Description
Single doses of inhaled placebo
Intervention Type
Drug
Intervention Name(s)
ETD001 multiple twice daily doses
Intervention Description
Ascending doses of inhaled ETD001 administered twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo multiple twice daily doses
Intervention Description
Doses of inhaled placebo administered twice daily
Intervention Type
Drug
Intervention Name(s)
ETD001 multiple once daily doses
Intervention Description
Doses of inhaled ETD001 administered once daily
Intervention Type
Drug
Intervention Name(s)
Placebo multiple once daily doses
Intervention Description
Doses of inhaled placebo administered once daily
Primary Outcome Measure Information:
Title
Number of participants reporting one or more treatment emergent adverse event (TEAE)
Time Frame
Baseline to Week 8
Title
Number of participants who discontinue due to an adverse event (AE)
Time Frame
Baseline to Week 8
Title
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
Title
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
Time Frame
Baseline to Week 8
Title
Number of participants who meet the markedly abnormal criteria for laboratory assessments at least once post dose
Time Frame
Baseline to Week 8
Title
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 Measure Information:
Title
Plasma concentrations of ETD001
Description
Blood levels of ETD001 measured after dosing
Time Frame
Day 1 pre-dose and at multiple time-points (up to 14 days) post final dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females using suitable methods of contraception, or females of non-childbearing potential Consent to study participation Body weight ≥ 50 kg and body mass index 19 - 30 kg/m2 Vital sign assessments within the normal ranges Healthy as determined following physical and laboratory examinations at screening visit Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value Exclusion Criteria: Acute or chronic illness detected at the screening visit Respiratory tract infection within 4 weeks of the screening visit Use of prescribed or OTC medication within 14 days of the screening visit History of regular alcohol use over the recommended limits within 6 months of screening, or history/evidence of alcohol or drug abuse Smoker or use of tobacco products within 6 months of screening Abnormal blood or urine laboratory test results at screening Recent participation (within 3 months) in another clinical trial Current, or history of, allergy that may be contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niyati Prasad, MD
Organizational Affiliation
Enterprise Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Hammersmith Medicines Research
City
London
ZIP/Postal Code
NW10 7EW
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects

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