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

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.

NCT Number	NCT07232121
Lead Sponsor	Dragonfly Therapeutics
Conditions	Healthy Participants, Healthy Adult Females, Healthy Adult Male, Healthy, Volunteer
Enrollment	48 participants
Start Date	2026-01-12
Primary Completion	2026-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-01