Healthy Volunteer
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, and PD of SC administration of single ascending doses of DR-01 in healthy volunteers.
Interventions
DRUGDR-01
DR-01 is a monoclonal antibody
OTHERPlacebo
Placebo
Sponsors
Dren Bio
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy, in the opinion of the Investigator, as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead ECGs. A subject with a clinical abnormality or laboratory parameter(s) outside the reference range that is not specifically listed in the inclusion or
Exclusion criteria
may be included if the Investigator (in consultation with the Medical Monitor) agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures, subject safety, or data interpretation. 2. Between 18 and 65 years of age, inclusive, of any race or gender. 3. Body weight at screening ≥ 40 kg and \< 120 kg, with body mass index between 18 and 35 kg/m2. 4. Adequate abdominal adipose tissue for SC injection. 5. Ability to understand and comply with protocol-required study procedures, including admission to the Clinical Research Unit the day prior to dosing with an overnight stay, and voluntarily sign a written informed consent document. 6. Use of a highly effective contraceptive measure (\< 1% failure rate; see Section 13.1) for all males and all females of childbearing potential during study and 90 days postdose for males and 30 days postdose for females. Bilateral tubal ligation performed 6 months prior to screening is considered a highly effective contraceptive measure for female subjects and female partners of male subjects and does not require the use of additional contraception. Females of childbearing potential must have a confirmatory negative urine pregnancy test on Day -1/prior to dosing on Day 1. Females who are not of childbearing potential (i.e., who are considered to be postmenopausal \[≥ 12 months of non-therapy amenorrhea\] or surgically sterile \[absence of ovaries and/or uterus or bilateral tubal ligation\]) are not required to have a pregnancy test or use contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and Severity of Treatment-Emergent Adverse Events [Safety and Tolerability] as assessed by CTCAE v5.0 after a single SC dose | Up to 57 days |
Countries
New Zealand
Outcome results
None listed