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HealthyPhase 1NCT05061277

Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Recifercept in Healthy Chinese Participants

A Phase 1 study testing Recifercept in people with Healthy, run by Pfizer at 2 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the pharmacokinetic (PK), safety, tolerability and immunogenicity of a single subcutaneous (SC) dose of the lyophilized formulation of recifercept in healthy Chinese participants. Read more about this study

Who is it for?
Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Recifercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesChina
Study dates
25 Oct 2023to 16 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Chinese male and female participants of nonchildbearing potential must be 21 to 55 years of age, inclusive at the time of signing the ICD.
  • Chinese male and female participants who are overtly healthy as determined by medical evaluation.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Participants must be of Chinese ethnicity (individuals currently residing in mainland China who were born in China and have both parents of Chinese descent).
  • Body mass index (BMI) of 19.0 to 27.5 kg/m2; and a total body weight >50 kg and ≤ 120 kg.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any condition possibly affecting drug absorption (eg, skin inflammation at infusion site, acne, rash, scarring, tattoos, erythema, sunburn, deep tanning, etc).
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or serological reaction of syphilis. Prior hepatitis B vaccination is allowed.
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the dose of study intervention.
  • Previous administration with an investigational drug/medical device within 30 days (or as determined by the local requirement) or 5 half lives preceding the dose of study intervention used in this study (whichever is longer).
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  • A positive urine drug test.
  • Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. Pulse rate > 100 beats/minute. Oral temperature (or ear temperature) > 37.5 ℃.
  • Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias).
  • Participants with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
  • aspartate aminotransferase (AST) or aspartate aminotransferase (ALT) level ≥ 1.5 × upper limit of normal (ULN);
  • Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is≤ ULN.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 201107

Other trials in China

About this study

Official title: A PHASE 1, OPEN-LABEL, SINGLE SUBCUTANEOUS DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF LYOPHILIZED FORMULATION OF RECIFERCEPT IN HEALTHY CHINESE PARTICIPANTS

The purpose of this study is to evaluate the pharmacokinetic (PK), safety, tolerability and immunogenicity of a single subcutaneous (SC) dose of the lyophilized formulation of recifercept in healthy Chinese participants.

Conditions
Healthy
Being tested
Recifercept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReciferceptDrug

    Also called PF-07256472

    A lyophilized powder for solution for injection

Study groups in NCT05061277
Study groupRoleWhat they receive
ReciferceptExperimentalA 300 mg single subcutaneous (SC) dose of recifercept for the treatment phase of study
Receives: Drug: Recifercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Concentration (Cmax)

    Measured: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose

  2. Time for Cmax (Tmax)

    Measured: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose

  3. Area Under the Serum Concentration Time Profile from Time Zero to 168 hrs (AUC0-168)

    Measured: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168 hours post-dose

  4. Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)

    Measured: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose

  5. Area Under the Serum Concentration Time Profile from Time 0 Extrapolated to Infinite Time (AUCinf)

    Measured: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose

  6. Terminal Elimination Half-Life (t½)

    Measured: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose

  7. Apparent Clearance (CL/F)

    Measured: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose

  8. Apparent Volume of Distribution (Vz/F)

    Measured: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose

Secondary outcomes (7)

  1. Incidence of Participants With Positive Anti-Drug Antibodies (ADA)

    Measured: 0, 168, 312, 504, 672 hours post-dose and maybe months 4 and/or month 7 post-dose

  2. Incidence of Participants With Positive Neutralizing Antibodies (NAb)

    Measured: Maybe 0, 168, 312, 504, 672 hours post-dose and maybe months 4 and/or month 7 post-dose

  3. Incidence of Adverse Events (AEs)

    Measured: Since inform consent form (ICD) is signed till up to about Day 29, or maybe till Month 4 or Month 7 post-dose, or when terminated/withdrawal from study

  4. Incidence of Clinical Laboratory Test Abnormalitiests

    Measured: Baseline to approximately Day 22, or up to approximately Month 4 or Month 7 post-dose, or when terminated/withwal from study

  5. Incidence of Participants With Clinically Relevant Changes in Vital Signs

    Measured: Baseline, within -3 hours pre-dose, and at 4, 24, 48, 72 hours post-dose, or up to approximately Month 4 or Month 7 post-dose, or when terminated/withdrawal from study

  6. Incidence of Participants With Clinically Relevant Changes in 12-lead Electrocardiogram (ECG)

    Measured: Baseline, within -3 hours pre-dose, and at 4, 24, 48, 72 hours post-dose, or up to approximately Month 4 or Month 7 post-dose, or when terminated/withdrawal from study

  7. Incidence of Participants With Infusion Site Reactions

    Measured: From time of signing inform concent form (ICD) to approximately Day 29, or up to approximately Month 4 or Month 7 post-dose, or when terminated/withdrawal from study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2021
  2. Study start25 Oct 2023 (estimated)
  3. Primary completion12 Dec 2023 (estimated)
  4. Study completion16 Jun 2024 (estimated)

Why it stopped: Pfizer has decided to cancel study C4181006 due to strategic considerations. This decision is not due to any specific reasons or requests from any regulatory authorities. No participants have been enrolled in this study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05061277
Sponsor's protocol ID
C4181006
Status last verified
Apr 2023
First submitted
20 Sep 2021
Last updated
18 Apr 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recifercept in people with Healthy, run by Pfizer at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Concentration (Cmax) (time frame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05061277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

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