A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 19, 2024

Primary Completion Date

February 6, 2025

Study Completion Date

February 6, 2025

Conditions
PK in Healthy Volunteers
Interventions
DRUG

PEG-MetHuG-CSF

Single dose of PEG-MetHuG-CSF will be given SC injection at 2 mg in Cohort 1 and 6 mg in Cohort 2

DRUG

Neulasta (Amgen)

Single dose of Neulasta will be given SC injection at 6 mg in Cohort 2b.

Trial Locations (1)

251020

Mackay Memorial Hospital, Taipei, Taiwan, Taipei

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novotech CRO

UNKNOWN

lead

PharmaEssentia

INDUSTRY

NCT06698861 - A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers | Biotech Hunter | Biotech Hunter