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Monoclonal Antibodies

Part 1: MK-5475 for Pulmonary Hypertension

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4 and 8 hours postdose, day 7: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4, 8 and 24 hours postdose

Summary

This trial is testing a new drug, MK-3475, for safety and effectiveness in reducing pulmonary vascular resistance (PVR) in people with PH-COPD. The hypothesis is that MK-3475 will be better than placebo at reducing PVR.

Eligible Conditions
  • Pulmonary Hypertension

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4 and 8 hours postdose, day 7: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4, 8 and 24 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4 and 8 hours postdose, day 7: predose, 5 minutes, 15 minutes, 0.5, 1, 2, 3, 4, 8 and 24 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage Change From Baseline to Day 28 in Pulmonary Vascular Resistance (PVR): Part 2
Percentage of Participants Who Discontinued Study Drug Due to an AE
Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)
Secondary study objectives
AUC0-24 Accumulation Ratio of MK-5475: Part 1
AUC0-24 of MK-5475: Part 2
AUC0-3 Accumulation Ratio of MK-5475: Part 2
+15 more

Side effects data

From 2022 Phase 1 trial • 22 Patients • NCT04370873
33%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (Part 2)
MK-5475 360 µg (Part 1)
Placebo (Part 1)
MK-5475 380 µg (Part 2)

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: MK-5475Experimental Treatment1 Intervention
Participants receive MK-5475 32 µg, 100 µg, 195 µg or 380 μg QD via inhalation from Days 1-28.
Group II: Part 1: MK-5475Experimental Treatment1 Intervention
Participants receive MK-5475 360 μg once daily (QD) via inhalation from Days 1-7. Following review of pharmacokinetic (PK) and safety data, a second 7 days of dosing may be initiated. A dose of up to 360 μg up to twice a day may be administered based on PK data in these participants.
Group III: Part 1: PlaceboPlacebo Group1 Intervention
Participants receive placebo QD via inhalation from Days 1-7.
Group IV: Part 2: PlaceboPlacebo Group1 Intervention
Participants receive placebo QD via inhalation from Days 1-28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-5475
2019
Completed Phase 3
~220

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,456 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,991 Previous Clinical Trials
5,180,664 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,872 Previous Clinical Trials
8,084,417 Total Patients Enrolled
~4 spots leftby Oct 2025
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