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NCT Number: NCT06137742

A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension

The purpose of the study is to learn how the study medicine called PF-07868489 is tolerated and acts in healthy adult people and people with pulmonary arterial hypertension (PAH).

Part A:

An investigator- and participant-blind, sponsor-open, placebo-controlled, single ascending dose study to assess the safety, tolerability, and pharmacokinetics (PK) of PF-07868489 in healthy adult participants.

Part B:

A 24-week, randomized, double blind, placebo-controlled study to assess the safety, tolerability, PK, and pharmacodynamics (PD) of PF-07868489 in adult participants with PAH.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria Part A:

  • overtly healthy
  • Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg.

Key Exclusion Criteria Part A:

  • clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, infections or allergic disease.
  • smoking more than 10 cigarettes (or equivalent) per day or smoking history ≥10 pack-years.

Key Inclusion Criteria Part B:

  • diagnosis of pulmonary arterial hypertension (PAH)
  • stable dose of standard of care PAH vasodilators
  • BMI 16 to 40 kg/m2; and a total body weight >45 kg.
  • 6MWD ≥ 150 and ≤ 450.
  • Pre-randomization RHC documenting a minimum of PVR ≥ 400 dyn ∙sec/cm5.

Key Exclusion Criteria Part B:

  • Any medical or psychiatric condition or laboratory abnormality.
  • Stopped receiving pulmonary hypertension chronic general supportive therapy 90 days prior to Day 1.
  • Pulmonary capillary wedge pressure > 15 mmHg on right heart catheterization (RHC) conducted during Screening.
  • History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients in investigational product.
  • Major surgery within 8 weeks prior to randomization.
  • Participants who smoke more than 10 cigarettes (or equivalent) per day or has a smoking history ≥10 pack-years.

Treatment and study plan

PF-07868489

Drug

Experimental Treatment

Placebo for PF-07868489

Drug

Placebo

Primary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to Day 113.

    Part A

  2. Number of Participants With Change From Baseline in Laboratory Tests Results

    Time frame: Baseline up to Day 113

    Part A

  3. Number of Participants With Vital Sign Abnormalities

    Time frame: Baseline up to Day 113

    Part A

  4. Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters

    Time frame: Baseline up to Day 113

    Part A

  5. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to Day 253

    Part B

  6. Number of Participants With Change From Baseline in Laboratory Tests Results

    Time frame: Baseline up to Day 253

    Part B

  7. Number of Participants With Vital Sign Abnormalities

    Time frame: Baseline up to Day 253

    Part B

  8. Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters

    Time frame: Baseline up to Day 253

    Part B

  9. Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week24

    Time frame: Baseline, Week 24

    repeated doses

Secondary outcomes

  1. Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)

    Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

    single dose

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

    Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

    single dose

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose

    single dose

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 4-7 days

    single dose

  5. Incidence of Anti-Drug Antibody (ADA)

    Time frame: Baseline and up to week 16

    single dose

  6. Plasma Decay Half-Life (t1/2)

    Time frame: Day 113

    single dose

  7. Minimum Observed Plasma Trough Concentration (Cmin)

    Time frame: Day 253

    repeat doses

  8. Plasma Decay Half-Life (t1/2)

    Time frame: Day 253

    repeat doses

  9. Incidence of Anti-Drug Antibody (ADA)

    Time frame: Baseline and up to Day 253

    repeated doses

  10. Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24

    Time frame: Baseline, Week 24

    repeated doses

  11. 6MWD

    Time frame: Baseline, Week 24

    repeated doses

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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