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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04543344

Enrollment

Registered

2020-09-10

Start date

2020-09-17

Completion date

2021-11-26

Last updated

2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGRecifercept

recifercept powder for solution for injection

OTHERPlacebo

solution for injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Only cohort 1 of the study is blinded.

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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).
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
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.
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

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026