A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults
Recruiting
Phase 1
Interventional Study
Healthy Participants
Healthy Adult Females
Healthy Adult Male
Healthy
Volunteer
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 48 (estimated)
- Sponsor
- Dragonfly Therapeutics · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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…
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