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RECRUITING
NCT07232121
PHASE1

A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults

Sponsor: Dragonfly Therapeutics

View on ClinicalTrials.gov

Summary

This is a double-blind, randomized, placebo-controlled, single ascending dose (SAD) study to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of DF5112 in healthy adult participants. A total of 48 participants are planned to be randomized into 6 cohorts. Additional cohorts at intermediate dose levels may be evaluated. Each cohort will include 8 healthy participants randomized to receive DF5112 or placebo through intravenous (IV) or subcutaneous (SC) administration. Following dose administration participants will be confined at the clinical research unit for observation for approximately 1 week and then will return for subsequent pre-identified follow up visits through Day 29.

Official title: A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacodynamics of DF5112 in Healthy Adult Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-01-12

Completion Date

2026-12

Last Updated

2026-04-01

Healthy Volunteers

Yes

Interventions

DRUG

DF5112

DF5112 administered IV or SC

OTHER

Placebo

Placebo administered IV or SC.

Locations (1)

Scientia Clinical Research Ltd

Sydney, New South Wales, Australia