Healthy Adult Volunteers
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety, tolerability, PK, PD, and immunogenicity of IV administered DR-0201 in healthy volunteers.
Interventions
DRUGDR-0201
DR-0201 is a bi-specific antibody
DRUGPlacebo
Placebo
Sponsors
Novotech
Dren Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key 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 for the population being studied that is not specifically listed in the inclusion or
Exclusion criteria
may be included if the Investigator (in consultation with the Medical Monitor) agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or data interpretation. 2. Between 18 and 55 years of age inclusive, at the time of signing the informed consent. 3. Body weight at screening ≥ 40 kg and \< 120 kg, with body mass index between 18 and 30 kg/m2. 4. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol, including the protocol-mandate hospitalization. 5. 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 post dose for males and 30 days post dose for females. Females of childbearing potential need to have a confirmatory urine pregnancy test on Day -1. Females who are not of childbearing potential (i.e., who are considered to be post-menopausal \[≥ 12 months of non-therapy amenorrhea\] or surgically sterile \[absence Key
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0 after a single IV dose | Up to 57 days |
Secondary
| Measure | Time frame |
|---|---|
| PK after a single IV dose: area under the plasma concentration time curve [AUC0-t]. | Up to 57 days |
| PK after a single IV dose: maximum observed plasma concentration [Cmax]. | Up to 57 days |
| PK after a single IV dose: time of occurrence of Cmax (tmax), | Up to 57 days |
| PK after a single IV dose: estimated half-life | Up to 57 days |
Countries
Australia
Outcome results
None listed