Actively Recruiting
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
Led by Dragonfly Therapeutics · Updated on 2026-04-01
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of DF5112 in healthy adult participants. This Phase 1, double-blind, randomized, placebo-controlled study involves single ascending doses of DF5112 given to healthy volunteers aged 18 to 55 years. The study aims to understand how the drug behaves in the body and any effects it may cause. Participants will be assigned to one of six groups, each with 8 healthy adults randomized to receive either a single dose of DF5112 or a placebo. The drug or placebo will be administered either intravenously or subcutaneously. Additional intermediate dose groups may be added. After receiving the dose, participants will remain in the clinical research unit for about one week for observation. Following this confinement period, participants will return for follow-up visits through Day 29 to monitor safety and collect data. Researchers will assess adverse events, measure drug levels in the body, and check for immune responses against the drug. The total study duration for each participant is approximately 29 days, including dosing, observation, and follow-up.
CONDITIONS
Brief 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 69 18.0 and 64 32.0 kg/m2 and body weight 69 45 kg.
- In good general health with no significant medical history as determined by the Principal Investigator.
- Clinical laboratory values within normal range or not clinically significant as assessed by the Principal Investigator.
You will not qualify if you...
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that affect drug absorption, metabolism, elimination, or pose risk.
- History of lymphoproliferative disease or any malignancy within the past 5 years, except treated skin cancers or certain non-invasive cancers.
- History of chronic or recurrent bacterial or fungal infections.
- Infection requiring systemic antibiotics within 90 days before dosing.
- Active oral infection.
- Acute illness within 2 weeks before screening or recent influenza or COVID within 4 weeks.
- Untreated latent or active tuberculosis.
- Positive or inconclusive hepatitis B or C antibody tests.
- Positive HIV antibody test.
- History of severe allergy or anaphylaxis to drugs or study drug components.
- Vaccination within 1 month before or planned within 1 month after Day 1; live vaccines within 1 month before or 3 months after Day 1.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From Day 1 dosing to Day 29
Participants receive a single dose of DF5112 or placebo administered either intravenously (IV) or subcutaneously (SC).
Approximately 1 dosing visit and multiple follow-up visits until Day 29
Trial Site Locations
Total: 1 location
1
Scientia Clinical Research Ltd
Sydney, New South Wales, Australia, 2031
Actively Recruiting
Research Team
C
Christopher Argent
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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