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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Drug: Recifercept

• Registration Number: NCT04543344
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-10
• Study Start: 2020-09-17
• Primary Completion: 2021-08-03
• Study Completion: 2021-11-26
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Repeated multiple doses
High Dose	Recifercept	Repeated multiple doses
Low Dose	Recifercept	Repeated multiple doses

Primary Outcome Measures

Name	Time	Method
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose	Time to reach Cmax
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)	0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose	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).
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose	Area under the concentration curve from time 0 to end of dosing interval (AUCtau)
Maximum Observed Plasma Concentration (Cmax)	0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose	Maximum Observed Plasma Concentration directly from data
Plasma Decay Half-Life (t1/2)	0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Accumulation Ratio (Rac)	0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose	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).

Secondary Outcome Measures

Name	Time	Method
Incidence of Anti-drug antibodies (ADA)	6 months post-dose	Incidence of participants who are ADA positive
Incidence of Neutralizing antibodies (NAb)	6 months post-dose	Incidence of participants who are NAb positive

Trial Locations

Locations (1)

Brussels Clinical Research Unit; 🇧🇪 Brussels, Bruxelles-capitale, Région DE, Belgium