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

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single or Multiple Subcutaneous Doses of Lyophilized Formulation of Recifercept in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543344
• Other study ID #: C4181004
• Secondary ID: 2020-000545-14
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2020
• Est. completion date: November 26, 2021

Study information

• Verified date: January 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 26, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male participants and female participants of nonchildbearing potential

• Participants who are overtly healthy

• Capable of giving signed informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Recifercept
recifercept powder for solution for injection

Other:
• Placebo
solution for injection

Locations

Country	Name	City	State
Belgium	Brussels Clinical Research Unit	Brussels	Bruxelles-capitale, Région DE

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Incidence of Anti-drug antibodies (ADA)	Incidence of participants who are ADA positive	6 months post-dose
Secondary	Incidence of Neutralizing antibodies (NAb)	Incidence of participants who are NAb positive	6 months post-dose

External Links

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