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A Comparative Evaluation of Pharmacokinetics and Immunogenicity.

NCT06918587 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-04-20

No results posted yet for this study

Summary

The Goal of these study is to evaluate and To compare the pharmacokinetics (PK) of the Test product (T) getting administered through prefilled syringe with on-body injector with Reference product as prefilled syringe following a single 6 mg dose administered through subcutaneous route in healthy adult Human subjects.

Subjects safety and immunogenicity will also be evaluated during these study as follows Safety - monitoring the adverse events , vitals signs, ECG, laboratory parameters, and injection site assessment.

Immunogenicity assessment- detection of ADA (Anti-PEG antibody levels ) and Nab (Neutralizing antibodies) will be done pre-dose and post dose on day 15 of each period.

Conditions

Interventions

DEVICE

TPI-120 with On body injector

TPI-120 pre-filled syringe 6 mg co-packaged with on-body injector, manufactured by: Kashiv Biosciences LLC, USA.

DRUG

Fylntera

Fylnetra Pre-Filled Syringe 6 mg, manufactured by: Kashiv Biosciences LLC, USA.

Sponsors & Collaborators

  • Kashiv BioSciences, LLC

    lead INDUSTRY

Principal Investigators

  • Dr Pallav Bharpoda, MBBS PGDCR · Kashiv biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-05
Primary Completion
2025-05-25
Completion
2025-05-25
FDA Drug
Yes

Countries

  • Jordan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06918587 on ClinicalTrials.gov