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C5001001 - A Phase 1/2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Escalating Doses of PF-07868489 in Healthy Adult Participants And, Additionally, Clinical Activity of Repeat Doses in Participants With Pulmonary Arterial Hypertension

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514064-17-00
Acronym
C5001001
Enrollment
32
Registered
2025-04-09
Start date
2025-05-23
Completion date
Unknown
Last updated
2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Brief summary

Incidence and severity of AE and SAEs., Change from baseline in vital signs., Change from baseline in clinical laboratory values., Change from baseline in ECG parameters (heart rate, QT, QTcF, PR, and QRS intervals)., Change from baseline at Week 24 of NTproBNP

Detailed description

PF-07868489 PK parameters after repeat doses; as data permit: Cmin, and t1/2, Incidence of the development of ADA against PF-07868489 following repeat doses., Change from baseline at 24 Week on (6-minute walk distance) 6MWD, Change from baseline at 24 Week on Pulmonary Vascular Resistance (PVR)

Interventions

DRUGPF-07868489
DRUGPF-07868489 Placebo

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence and severity of AE and SAEs., Change from baseline in vital signs., Change from baseline in clinical laboratory values., Change from baseline in ECG parameters (heart rate, QT, QTcF, PR, and QRS intervals)., Change from baseline at Week 24 of NTproBNP—

Secondary

MeasureTime frame
PF-07868489 PK parameters after repeat doses; as data permit: Cmin, and t1/2, Incidence of the development of ADA against PF-07868489 following repeat doses., Change from baseline at 24 Week on (6-minute walk distance) 6MWD, Change from baseline at 24 Week on Pulmonary Vascular Resistance (PVR)—

Countries

Belgium, Czechia, France, Germany, Greece, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026