NCT07232121

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Dragonfly Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants
• Healthy Adult Females
• Healthy Adult Male
• Healthy
• Volunteer

Interventions

Type	Name	Description
DRUG	DF5112	DF5112 administered IV or SC
OTHER	Placebo	Placebo administered IV or SC.

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-11-18
• Last updated: 2026-04-01

Locations

1 site across 1 country: Australia