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Not Yet Recruiting
NCT05677347
Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Conditions: Pulmonary Disease, Chronic Obstructive
Sex: All
Ages: 40 Years – 70 Years
Phase: PHASE1
Enrollment: 12
Sponsor: GlaxoSmithKline
Summary
This is a two parts study, a single ascending dose followed by 14-days repeat dosing.
The single ascending dose part will assess two dose levels of GSK3923868 or placebo across two treatment periods 1 and 2 in a single cohort of participants with a washout period of a minimum of 5 days after each treatment periods.
The repeat dose part will assess repeated one dose level of GSK3923868 or placebo in treatment period 3 with up to 14 days of follow up in the same cohort of participants.
The duration of study participation for treatment period 1, 2 and 3 will be 6, 6 and up to 29 days (including follow up), respectively.
Eligibility Criteria
Inclusion Criteria:Between 40 and 70 years of age.Confirmed diagnosis of COPD for greater than (>) 6 months.Participant is a smoker or an ex-smoker with a smoking history of at least 10 pack years.A female participant is eligible to participate if she is not pregnant or breastfeeding and agrees to use contraceptives during the study (for women of childbearing potential only).Exclusion Criteria:Participant has poorly controlled or unstable COPD.Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled.Participant has had a respiratory tract infection treated with antibiotics within 4 weeks prior to screening.Participant requires regular treatment with oral corticosteroids or has received a course of oral or parenteral corticosteroids within 4 weeks prior to screening.Participant requires long-term oxygen therapy.Current enrolment or past participation in a clinical trial within 30 days before this study starts.Positive tests for human immunodeficiency virus (HIV), hepatitis B and C, or Coronavirus disease-19 (COVID-19).Positive pre-study drug (except for as results of opioids prescribed for medical reasons and/or inadvertent consumption of poppy seeds) /alcohol screening result.
Source: ClinicalTrials.gov (NCT05677347). StuddyBuddy aggregates publicly available trial information.