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

Enterprise Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ETD002 - single dose; Drug: Placebo - single dose; Drug: Placebo - 7 day repeat dose; Drug: ETD002 - 7 day repeat dose; Drug: ETD002 - 14 day repeat dose; Drug: Salbutamol; Drug: Placebo - 14 day repeat dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04488705

2020-001080-92 (EudraCT Number)

ET-TMEM-01

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups

Single ascending dose

Experimental group

Treatment:

Drug: Placebo - single dose

Drug: ETD002 - single dose

Repeat dose - 7 days

Experimental group

Treatment:

Drug: ETD002 - 7 day repeat dose

Drug: Placebo - 7 day repeat dose

Repeat dose - 14 days

Experimental group

Treatment:

Drug: Placebo - 14 day repeat dose

Drug: ETD002 - 14 day repeat dose

Repeat dose - 7 days with SABA

Experimental group

Treatment:

Drug: Salbutamol

Drug: ETD002 - 7 day repeat dose

Drug: Placebo - 7 day repeat dose