Healthy Volunteers
Conditions
Keywords
CLYM116, APRIL, monoclonal antibody, healthy volunteers, Phase 1, IgA nephropathy, MIL116
Brief summary
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
Detailed description
CLYM116 is a humanized monoclonal antibody that selectively binds to a proliferation inducing ligand (APRIL). This is a Phase 1, randomized, double-blind, placebo-controlled, single-center study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of CLYM116 in adult normal healthy volunteers (NHVs). The study will enroll up to 48 subjects, across up to five cohorts.
Interventions
DRUGCLYM116
CLYM116 to be administered by SC injection
DRUGPlacebo
Placebo solution to be administered at a matching volume by SC injection
Sponsors
Climb Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult males and females aged 18-60 years, inclusive * 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 4 months post-dose * Completion of COVID-19 vaccination according to local guidelines, as well as influenza vaccination (within 12 months)
Exclusion criteria
* Prior treatment with investigational drugs within 30 days or 5 half-lives * Previous or current hypogammaglobulinemia * Current presence of allergic reactions considered clinically significant * Positive tests for HIV, hepatitis B/C, syphilis, or tuberculosis * Tobacco use (\>2 cigarettes/day), alcohol abuse, or drug abuse * Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of single and multiple ascending doses of CLYM116 in healthy volunteers Incidence of treatment-emergent adverse events | From Screening through to Day 85, or final follow-up visit |
| Incidence of injection site reactions Number of injection site reactions | From Baseline through to Day 4 and Day 15 to Day 18 |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) Measurement of the maximum observed plasma concentration. | From Baseline through to Day 85 (except Day 14), or final follow-up visit |
| Time to Maximum Observed Concentration (Tmax) Measurement of the time to maximum observed concentration. | From Baseline through to Day 85 (except Day 14), or final follow-up visit |
| Area Under the Curve (AUC) Measurement of the area under the drug concentration-time curve. | From Baseline through to Day 85 (except Day 14), or final follow-up visit. |
| Half-Life (T1/2) Measurement of the half-life in days | From Baseline through to Day 85 (except Day 14), or final follow-up visit |
| Levels of Immunoglobulins Measurement of Immunoglobulins and changes over time | From Screening through to Day 85, or final follow-up visit |
| Level of APRIL Measurement of APRIL in pg/mL and changes over time | Day -1, Baseline, Day 1, Day 4, Day 8, Day 14, Day 15, Day 17, Day 18, Day 22, Day 29, Day 71, day 85, final follow up visit |
| Immunogenicity Measurement of CLYM116 antidrug antibodies (ADA) | Baseline, Day 15, Day 29, Day 43, Day 71, Day 85, follow-up visit |
Countries
Australia
Contacts
CONTACTClimb Bio Study Director
Outcome results
None listed