Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept

NCT04543344 | Completed Phase 1

• 2 other identifiers: C41810042020-000545-14
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a single center, randomized, parallel group, repeated dose study of recifercept (Cohort 1 and Cohort 2) or placebo (only in Cohort 1) in approximately 18 healthy participants, using 2 cohorts (N = 9) at two dose levels of recifercept.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

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

  AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).

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

• Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

  Area under the concentration curve from time 0 to end of dosing interval (AUCtau)

  0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose

• Maximum Observed Plasma Concentration (Cmax)

  Maximum Observed Plasma Concentration directly from data

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

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Time to reach Cmax

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

• Plasma Decay Half-Life (t1/2)

  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

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

• Accumulation Ratio (Rac)

  Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from time 0-t (Day X) divided by AUC from time 0-t (Day 1).

  0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose

Secondary Outcomes (2)

• Incidence of Anti-drug antibodies (ADA)

  6 months post-dose

• Incidence of Neutralizing antibodies (NAb)

  6 months post-dose

Study Arms (3)

Low Dose

EXPERIMENTAL

Repeated multiple doses

Drug: Recifercept

placebo

PLACEBO COMPARATOR

Repeated multiple doses

Other: Placebo

High Dose

EXPERIMENTAL

Repeated multiple doses

Drug: Recifercept

Interventions

Recifercept DRUG

recifercept powder for solution for injection

Also known as: PF-07256472

High Dose; Low Dose

Placebo OTHER

solution for injection

placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male participants and female participants of nonchildbearing potential
• Participants who are overtly healthy
• Capable of giving signed informed consent

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Brussels Clinical Research Unit

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Only cohort 1 of the study is blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 10, 2020
• Study Start: September 17, 2020
• Primary Completion: August 3, 2021
• Study Completion: November 26, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)