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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Healthy Participants; Healthy Adult Females; Volunteer; Healthy Adult Male
• Intervention / Treatment: Drug: DF5112; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Christopher Argent; Phone Number: +61 2 9382 5844; Email: christopher.argent@scientiaclinicalresearch.com.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2031
      • Recruiting
      • Scientia Clinical Research Ltd
      • Principal Investigator: Christopher Argent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Male or female participants aged 18 to 55 years (inclusive) at the time of informed consent.
• Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg.
• At the discretion of the Principal Investigator (PI) or designee, in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP.
• Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.

Key Exclusion Criteria:

• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the PI or designee, are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
• History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases (except for squamous and basal cell carcinoma of the skin or actinic keratoses that have been treated with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
• History of or evidence of recurrent or chronic bacterial or fungal infections including those of the skin, vagina, oral cavity, etc., or systemic fungal infection.
• History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 90 days prior to dosing on Day 1.
• Active oral infection.
• Acute illness (e.g. common cold) within 2 weeks prior to Screening, or seasonal influenza or COVID within 4 weeks prior to Screening.
• History of latent or active tuberculosis that has not been adequately treated, at the discretion of the PI or designee.
• Positive or inconclusive hepatitis B or hepatitis C based antibody tests at Screening.
• Positive human immunodeficiency virus (HIV) antibody test at Screening.
• History of severe allergy, hypersensitivity reaction, or anaphylaxis to drugs or human proteins or components of the study drug formulation used in this study.
• Any vaccination within 1 month of Day 1 and planned within 1 month post Day 1. Any live or attenuated vaccine within 1 month prior to Day 1 and planned within 3 months post Day 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DF5112; Single dose of DF5112 administered either via IV or SC	Drug: DF5112; DF5112 administered IV or SC
Placebo Comparator: Placebo; Single dose of placebo administered either via IV or SC	Other: Placebo; Placebo administered IV or SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Treatment Emergent Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0	From Day 1 dosing to end of study at Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the PK of single ascending doses of DF5112 administered by IV or SC injection	PK parameter: Area Under the Concentration Curve (AUC)	From Day 1 dosing to end of study at Day 29
Incidence and titer of Anti-Drug Antibodies		From Day 1 dosing to end of study at Day 29

Collaborators and Investigators

• Sponsor: Dragonfly Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteer; Healthy Participant
• Other Study ID Numbers: DF5112-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No