Clinical trial NCT05061277: Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Recifercept in Healthy Chinese Participants
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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.

Primary outcomes:
measure: Maximum Observed Concentration (Cmax)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose
measure: Time for Cmax (Tmax)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose
measure: Area Under the Serum Concentration Time Profile from Time Zero to 168 hrs (AUC0-168)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168 hours post-dose
measure: Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose
measure: Area Under the Serum Concentration Time Profile from Time 0 Extrapolated to Infinite Time (AUCinf)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose
measure: Terminal Elimination Half-Life (t½)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose
measure: Apparent Clearance (CL/F)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 264, 312, 504 hours post-dose
Secondary outcomes:
measure: Incidence of Participants With Positive Anti-Drug Antibodies (ADA)
timeFrame: 0, 168, 312, 504, 672 hours post-dose and maybe months 4 and/or month 7 post-dose
measure: Incidence of Participants With Positive Neutralizing Antibodies (NAb)
timeFrame: Maybe 0, 168, 312, 504, 672 hours post-dose and maybe months 4 and/or month 7 post-dose
measure: Incidence of Adverse Events (AEs)
timeFrame: 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
measure: Incidence of Clinical Laboratory Test Abnormalitiests
timeFrame: Baseline to approximately Day 22, or up to approximately Month 4 or Month 7 post-dose, or when terminated/withwal from study
measure: Incidence of Participants With Clinically Relevant Changes in Vital Signs
timeFrame: 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
measure: Incidence of Participants With Clinically Relevant Changes in 12-lead Electrocardiogram (ECG)
timeFrame: 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
measure: Incidence of Participants With Infusion Site Reactions
timeFrame: 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
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: