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

• Sponsor: Pfizer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06137742
• Collaborator: (none)
• Enrollment: 90
• Arms: 2
• Anticipated Duration (Months): 28.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: PF-07868489; Drug: Placebo for PF-07868489	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Part A is a sequential study. Part B is a parallel group study.Part A is a sequential study. Part B is a parallel group study.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Part A is an investigator- and participant-blind, sponsor-open, placebo-controlled, single ascending dose. Part B is a 24-week, randomized, double blind (pharmacist unblinded), placebo-controlled study.
• Primary Purpose: Basic Science
• Official Title: A PHASE 1, 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 REPEAT DOSES IN PARTICIPANTS WITH PULMONARY ARTERIAL HYPERTENSION
• Anticipated Study Start Date: Nov 14, 2023
• Anticipated Primary Completion Date: Apr 7, 2026
• Anticipated Study Completion Date: Apr 7, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-07868489 single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)	Drug: PF-07868489; Experimental Treatment
Placebo Comparator: Placebo single subcutaneous injection (Part A); 6 subcutaneous injections at regular intervals (Part B)	Drug: Placebo for PF-07868489; Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Day 113.]

   Part A

2. Number of Participants With Change From Baseline in Laboratory Tests Results [Baseline up to Day 113]

   Part A

3. Number of Participants With Vital Sign Abnormalities [Baseline up to Day 113]

   Part A

4. Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters [Baseline up to Day 113]

   Part A

5. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Day 281]

   Part B

6. Number of Participants With Change From Baseline in Laboratory Tests Results [Baseline up to Day 281]

   Part B

7. Number of Participants With Vital Sign Abnormalities [Baseline up to Day 281]

   Part B

8. Number of Participants With Change From Baseline in Electrocardiogram (ECG) Parameters [Baseline up to Day 281]

   Part B

Secondary Outcome Measures

1. Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast) [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) [Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose]

   single dose

3. Maximum Observed Plasma Concentration (Cmax) [Pre dose, 8, 12, 24, 48,72,96,168,336 hours post dose]

   single dose

4. Time to Reach Maximum Observed Plasma Concentration (Tmax) [4-7 days]

   single dose

5. Incidence of Anti-Drug Antibody (ADA) [Baseline and up to week 16]

   single dose

6. Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Week24 [Baseline, week 24]

   repeated doses

7. Plasma Decay Half-Life (t1/2) [20 days]

   single dose

8. Minimum Observed Plasma Trough Concentration (Cmin) [week 4]

   repeat doses

9. Plasma Decay Half-Life (t1/2) [20 days]

   repeat doses

10. Incidence of Anti-Drug Antibody (ADA) [Baseline and up to week 40]

    repeated doses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT06137742
• Other Study ID Numbers: C5001001
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: pulmonary; high lung artery pressure
• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension

Study Results

No Results Posted as of Nov 18, 2023