Recent Updates
Recently added Catalysts

penicillin G benzathine

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Oct 10, 2018

penicillin G benzathine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2018

penicillin G benzathine target and mechanism

ModalitySmall molecule

Also known as penicillin G, benzathine benzylpenicillin

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

penicillin G benzathine clinical trials

penicillin G benzathine · 1 trial · 1 indication

Phase 1 1
NCT03612557A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy SubjectsHealthy
COMPLETED8 Analytics
PHASE1COMPLETED
A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed plasma concentration for penicillin G (Cmax)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Time to Cmax (Tmax)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Area under the plasma concentration time curve from time zero to the time of the last measurable concentration (AUClast)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Area under the plasma concentration time curve from time zero extrapolated to infinite time (as data permit)(AUCinf)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Apparent clearance (as data permit) (CL/F)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Apparent volume of distribution (as data permit) (Vz/F)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose
Terminal half life (as data permit) (t1/2)
0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose

Secondary Endpoints

Number of Subjects experiencing an Adverse Event
Screening up to 28 days after last dose of study medication
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
active treatment armEXPERIMENTALpenicillin G benzathine treatment

Interventions

NameTypeDescription
penicillin G benzathineDRUG2.4 million units (IM) of benzathine benzylpenicillin
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female subjects (of childbearing or nonchildbearing potential) and/or male subjects * Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg and \<100 kg. Exclusion Criteria: • Evidence or history of clinically significant hematological, renal, ...

Countries:Japan
Unlock Eligibility Criteria

Frequently asked questions about penicillin G benzathine

What is penicillin G benzathine?

Penicillin G benzathine is a small molecule antibiotic developed by Pfizer, Inc. (ticker PFE). It is an intramuscular injectable form of penicillin. The program is in Phase 1 clinical development, and the specific indications being studied are undisclosed. It is investigational and has not been approved for the indications under study.

Who makes penicillin G benzathine?

Penicillin G benzathine is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program for this injectable antibiotic.

What phase is penicillin G benzathine in?

Penicillin G benzathine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved for the undisclosed indications being studied.

What clinical trials is penicillin G benzathine in?

Penicillin G benzathine has been studied in one completed Phase 1 trial, NCT03612557, titled A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects. The trial enrolled 8 healthy volunteers in Japan, was uncontrolled, and was not randomized or double blinded.

Is penicillin G benzathine FDA approved?

Penicillin G benzathine is an investigational product in Phase 1 clinical development and has not been approved for the undisclosed indications under study. The only listed trial, NCT03612557, was a completed Phase 1 study in healthy Japanese subjects.