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PRA-216 COPD Safety and Biomarker Study

ConditionChronic Obstructive Pulmonary Disease (COPD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorPrana Therapies Inc

About this trial

This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with chronic obstructive pulmonary disease (COPD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 40-80

Willing and able to attend all study visits, comply with study requirements.

Able and willing to provide written informed consent

Documented COPD diagnosis prior for at least 12 months prior to screening.

Disqualifiers

Evidence of clinically significant pulmonary condition or disease other than COPD

Any physical or psychological condition that prohibits study completion

Known history of illicit drug use or drug abuse, harmful alcohol use (at the Investigator's discretion), alcoholism within 12 months prior to the first dose of study agent

History of severe allergic reactions or hypersensitivity

Trial design

Design model

Parallel

Treatments tested in this trial

  • PRA-216

    Drug

    biologic

  • Placebo

    Drug

    matching placebo for PRA-216

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Active PRA-216Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of PRA-216 in patients with moderate to severe COPD

Time frame
40 weeks

Secondary outcomes

1

The effect of multiple doses of PRA-216 compared to placebo on exhaled nitric oxide (FeNO) in COPD participants

FeNO is a non-invasive biomarker of airway inflammation in COPD. A higher number indicates higher inflammation. A reduction in FeNO levels will indicate functional activity of PRA-216.

Time frame
40 weeks
2

Pharmacokinetics of PRA-216: T1/2 in patients with COPD

Terminal elimination half-life of PRA-216 in plasma

Time frame
40 weeks
3

Pharmacokinetics of PRA-216: AUC in patients with COPD

Area under the curve of PRA-216 in plasma

Time frame
40 weeks
4

Pharmacokinetics of PRA-216: Cmax in patients with COPD

Maximum concentration of PRA-216 in plasma.

Time frame
40 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prana Therapies Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: