Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06137742




Registration number
NCT06137742
Ethics application status
Date submitted
14/11/2023
Date registered
18/11/2023
Date last updated
2/07/2025

Titles & IDs
Public title
A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
Scientific 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
Secondary ID [1] 0 0
2024-514064-17-00
Secondary ID [2] 0 0
C5001001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-07868489
Treatment: Drugs - Placebo for PF-07868489

Experimental: PF-07868489 - single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)

Placebo comparator: Placebo - single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)


Treatment: Drugs: PF-07868489
Experimental Treatment

Treatment: Drugs: Placebo for PF-07868489
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline up to Day 113.
Primary outcome [2] 0 0
Number of Participants With Change From Baseline in Laboratory Tests Results
Timepoint [2] 0 0
Baseline up to Day 113
Primary outcome [3] 0 0
Number of Participants With Vital Sign Abnormalities
Timepoint [3] 0 0
Baseline up to Day 113
Primary outcome [4] 0 0
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Timepoint [4] 0 0
Baseline up to Day 113
Primary outcome [5] 0 0
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [5] 0 0
Baseline up to Day 253
Primary outcome [6] 0 0
Number of Participants With Change From Baseline in Laboratory Tests Results
Timepoint [6] 0 0
Baseline up to Day 253
Primary outcome [7] 0 0
Number of Participants With Vital Sign Abnormalities
Timepoint [7] 0 0
Baseline up to Day 253
Primary outcome [8] 0 0
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters
Timepoint [8] 0 0
Baseline up to Day 253
Primary outcome [9] 0 0
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24
Timepoint [9] 0 0
Baseline, Week 24
Secondary outcome [1] 0 0
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
Timepoint [1] 0 0
Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Secondary outcome [2] 0 0
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Timepoint [2] 0 0
Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Secondary outcome [3] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [3] 0 0
Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose
Secondary outcome [4] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Timepoint [4] 0 0
4-7 days
Secondary outcome [5] 0 0
Incidence of Anti-Drug Antibody (ADA)
Timepoint [5] 0 0
Baseline and up to week 16
Secondary outcome [6] 0 0
Plasma Decay Half-Life (t1/2)
Timepoint [6] 0 0
Day 113
Secondary outcome [7] 0 0
Minimum Observed Plasma Trough Concentration (Cmin)
Timepoint [7] 0 0
Day 253
Secondary outcome [8] 0 0
Plasma Decay Half-Life (t1/2)
Timepoint [8] 0 0
Day 253
Secondary outcome [9] 0 0
Incidence of Anti-Drug Antibody (ADA)
Timepoint [9] 0 0
Baseline and up to Day 253
Secondary outcome [10] 0 0
PVR
Timepoint [10] 0 0
Baseline, Week 24
Secondary outcome [11] 0 0
6MWD
Timepoint [11] 0 0
Baseline, Week 24

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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 32 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/02/2027
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Wesley Research Institute - Auchenflower
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Rhode Island
Country [4] 0 0
Belgium
State/province [4] 0 0
Bruxelles-capitale, Région DE
Country [5] 0 0
China
State/province [5] 0 0
Guangdong
Country [6] 0 0
China
State/province [6] 0 0
Hunan
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
Germany
State/province [8] 0 0
Baden-württemberg
Country [9] 0 0
Germany
State/province [9] 0 0
Hessen
Country [10] 0 0
Germany
State/province [10] 0 0
Sachsen
Country [11] 0 0
Italy
State/province [11] 0 0
Monza E Brianza
Country [12] 0 0
Japan
State/province [12] 0 0
Hyogo
Country [13] 0 0
Japan
State/province [13] 0 0
Kanagawa
Country [14] 0 0
Japan
State/province [14] 0 0
Miyagi
Country [15] 0 0
Japan
State/province [15] 0 0
Okayama
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Incheon-gwangyeoksi [incheon]
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul-teukbyeolsi [seoul]
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid, Comunidad DE
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
United Kingdom
State/province [20] 0 0
London, CITY OF
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Clydebank

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06137742