Actively Recruiting
A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults
Led by Dragonfly Therapeutics · Updated on 2026-04-01
48
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 55 years (inclusive) at the time of informed consent.
- Body mass index (BMI) between 65 18.0 and 4 32.0 kg/m2 and body weight 65 45 kg.
- In good general health, with no significant medical history and no clinically significant abnormalities on physical examination at Screening and/or before first administration of study drug.
- Clinical laboratory values within normal range, unless deemed not clinically significant by the Principal Investigator or designee.
You will not qualify if you...
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that may alter drug absorption, metabolism, elimination, or pose risk.
- History of lymphoproliferative disease or any known malignancy or history of malignancy within the past 5 years (with some exceptions).
- History or evidence of recurrent or chronic bacterial or fungal infections.
- Infection requiring treatment with systemic antibiotics within 90 days prior to dosing.
- Active oral infection.
- Acute illness within 2 weeks prior to Screening or seasonal influenza or COVID within 4 weeks prior to Screening.
- History of latent or active tuberculosis not adequately treated.
- Positive or inconclusive hepatitis B or hepatitis C antibody tests at Screening.
- Positive HIV antibody test at Screening.
- History of severe allergy, hypersensitivity, or anaphylaxis to drugs or study drug components.
- Any vaccination within 1 month before 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Scientia Clinical Research Ltd
Sydney, New South Wales, Australia, 2031
Actively Recruiting
Research Team
C
Christopher Argent
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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