Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Not yet recruiting
• Trial end date: 2023-08-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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.