Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Intervention: CCI15106; Placebo
Intervention description: One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.; One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this study, subjects will be randomized to receive either study drug or placebo in a parallel manner.
Masking: Double (Participant, Investigator)
Masking description: This is a double blind, randomized study and subject and investigator will be blinded.
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bystander; inhalation powder; monodose device; COPD; pharmacokinetics; safety; Healthy; CCI15106; tolerability

Summary:

      This single and repeat increasing dose study will collect information on safety, tolerability
      and drug levels in the body of the CCI15106 inhalation powder. The study will also look at
      the level of CCI15106 that will be released into the air and may be found in the blood of the
      people standing around the person inhaling it (bystanders). This is a two-part study in which
      Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part
      2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and
      approximately 22 subjects with COPD will be randomized in this study for dosing. The total
      study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C
      Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.
    

Eligibility criteria:

        Some important Inclusion Criteria:

        For healthy subjects and bystanders:

          -  18 to 65 years of age.

          -  Healthy as determined by a doctor.

          -  Men who agree to use contraception during the treatment period and for at least 7
             months after the last dose of study medicine and agree not to donate sperm during this
             period.

          -  Women who are not pregnant or breastfeeding, and not of childbearing potential.

        For subjects with COPD:

          -  40 to 75 years of age.

          -  Diagnosed with moderate COPD by a doctor.

          -  Have breathing test results that are consistent with moderate COPD as defined in the
             study protocol.

          -  A smoker or an ex-smoker.

          -  Men who agree to use contraception during the treatment period and for at least 7
             months after the last dose of study medicine and agree not to donate sperm during this
             period.

          -  Women who are not pregnant or breastfeeding, and not of childbearing potential.

        Some Important Exclusion Criteria:

        For healthy subjects and bystanders:

          -  History of liver disease.

          -  Use of over-the-counter or prescription drugs (including vitamins) 7 days before the
             study until completion of the follow-up visit.

          -  Participation in the study would result in loss of more than 500 milliliter (mL) of
             blood within 3 months.

          -  Participation in another clinical trial with an investigational product within about 3
             months before this study.

          -  Positive drug/alcohol screen.

          -  Regular use of known drugs of abuse.

          -  Regular alcohol consumption within 3 months before the study.

          -  Breath test indicative of smoking at study start.

          -  Documented lactose allergy/intolerance.

          -  Men whose partner is pregnant or breastfeeding cannot participate.

          -  Certain blood test results may not allow subjects to participate, as described in the
             study protocol.

        For subjects with COPD:

          -  History of liver disease.

          -  Poorly controlled COPD disease as, for example, more than 2 exacerbations of COPD per
             year.

          -  Some respiratory conditions, like for example active tuberculosis, lung cancer or any
             other respiratory condition. Subjects with other respiratory conditions (for example,
             clinically significant: asthma, pulmonary fibrosis, bronchiectasis) are excluded if
             these conditions are the primary cause of their respiratory symptoms.

          -  Unstable or uncontrolled cardiac disease.

          -  Problems with kidney function as defined in the study protocol.

          -  Past or current medical conditions or diseases that are not well controlled.

          -  Subjects are not allowed to take oral corticosteroids from 4 weeks prior to screening
             and for the duration of the study.

          -  Subjects taking medications for any chronic conditions have to be on stable doses for
             4 weeks before screening and until after study treatment is finished.

          -  Use of short-acting inhaled bronchodilators is allowed, but subjects must be able to
             stop their medications several times during the study.

          -  Use of long-acting bronchodilators is allowed, but subjects must be able to change the
             schedule of their medications twice during the study.

          -  Participation in the study would result in loss of more than 500 mL within 3 months.

          -  Participation in another clinical trial with an investigational product within about 3
             months before this study.

          -  Positive drug/alcohol screen.

          -  Regular use of known drugs of abuse.

          -  Regular alcohol consumption within 3 months before the study.

          -  Unable to refrain from smoking for certain periods during the study (maximum about 6
             hours).

          -  Documented lactose allergy/intolerance.

          -  Men whose partner is pregnant or breastfeeding cannot participate.

          -  Certain blood test results may not allow subjects to participate, as described in the
             study protocol.