Healthy Volunteers
Conditions
Keywords
healthy, volunteer
Brief summary
The main objective is to assess the safety and tolerability of subcutaneous and intravenous injection forms of budoprutug in healthy volunteers.
Detailed description
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of budoprutug administered subcutaneously (SC) in adult normal healthy volunteers (NHVs). To assess the bioavailability of the SC formulation, one cohort will receive a single intravenous (IV) dose of budoprutug. Approximately 38 participants will be enrolled across four dose cohorts, including three SC dose levels and one IV comparator group.
Interventions
DRUGBudoprutug
Subcutaneous or IV administration
DRUGPlacebo
Placebo comparator
Sponsors
Climb Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult males and females aged 18-60 years * Body mass index (BMI) between 18 and 32 kg/m² and weight between 45 and 110 kg * Clinically normal medical history, physical exam, ECG, and laboratory results (or abnormalities deemed not clinically significant) * Willing and able to comply with study procedures and provide informed consent * Women of childbearing potential must use highly effective contraception and have negative pregnancy tests * Men must use contraception and refrain from sperm donation for 6 months post-dose * Completion of a 2-dose primary COVID-19 vaccination series and at least 1 booster dose, as well as influenza vaccination (within 12 months)
Exclusion criteria
* Prior treatment with investigational drugs within 30 days or 5 half-lives * History of hypogammaglobulinemia or significant allergic reactions * Recent infections, including serious local/systemic infections or opportunistic infections * Positive tests for HIV, hepatitis B/C, syphilis, or tuberculosis * Use of tobacco (\>2 cigarettes/day), alcohol abuse, or recreational drugs * Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants | Day 57 | Incidence of treatment-emergent adverse events |
| Incidence of infusion-related reactions (IRRs) for IV administration | Day 57 | Number of infusion-related reactions |
| Incidence of injection site reactions (ISRs) for SC administration | Day 57 | Number of injection site reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Day 57 | Measurement of the maximum observed plasma concentration. |
| Time to Maximum Observed Concentration (Tmax) | Day 57 | Measurement of the time to maximum observed concentration. |
| Area Under the Curve (AUC) | Day 57 | Measurement of the area under the drug concentration-time curve. |
| Terminal Half-Life (T1/2) | Day 57 | Measurement of the terminal half-life in days. |
| Bioavailability (F) | Day 57 | Relative absorption of SC vs IV budoprutug (%). |
Countries
Australia
Outcome results
None listed