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

Enterprise Therapeutics

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: Placebo multiple twice daily doses; Drug: ETD001 multiple twice daily doses; Drug: ETD001 single dose; Drug: Placebo multiple once daily doses; Drug: ETD001 multiple once daily doses; Drug: Placebo single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04926701

ET-ENAC-01

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 3 patient groups

Single ascending dose

Experimental group

Description:

Single dose of inhaled ETD001/placebo on one occasion

Treatment:

Drug: Placebo single dose

Drug: ETD001 single dose

Multiple ascending dose (7 days)

Experimental group

Description:

Daily doses of ETD001/placebo for 7 consecutive days

Treatment:

Drug: Placebo multiple twice daily doses

Drug: ETD001 multiple twice daily doses

Drug: Placebo multiple once daily doses

Drug: ETD001 multiple once daily doses

Multiple ascending dose (14 days)

Experimental group

Description:

Daily doses of ETD001/placebo for 14 consecutive days

Treatment:

Drug: Placebo multiple twice daily doses

Drug: ETD001 multiple twice daily doses