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A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults
Sponsor: Dragonfly Therapeutics
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
DF5112
DF5112 administered IV or SC
Placebo
Placebo administered IV or SC.
Locations (1)
Scientia Clinical Research Ltd
Sydney, New South Wales, Australia