Healthy volunteers Other
Conditions
Interventions
CLYM116 is a humanized monoclonal antibody that selectively binds to a proliferation-inducing ligand (APRIL). This is a phase I, randomized, double-blind, placebo-controlled, single-center study desig
Sponsors
Climb Bio, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult males and females aged 18-60 years, inclusive 2. Body mass index (BMI) between 18 and 32 kg/m² and weight between 45 and 110 kg 3. Clinically normal medical history, physical exam, ECG, and laboratory results (or abnormalities deemed not clinically significant) 4. Willing and able to comply with study procedures and provide informed consent 5. Women of childbearing potential must use highly effective contraception and have negative pregnancy tests 6. Men must use contraception and refrain from sperm donation for 4 months post-dose 7. Completion of COVID-19 vaccination according to local guidelines, as well as influenza vaccination (within 12 months)
Exclusion criteria
Exclusion criteria: 1. Prior treatment with investigational drugs within 30 days or 5 half-lives 2. Previous or current hypogammaglobulinemia 3. Current presence of allergic reactions considered clinically significant 4. Positive tests for HIV, hepatitis B/C, syphilis, or tuberculosis 5. Tobacco use (>2 cigarettes/day), alcohol abuse, or drug abuse 6. Recent live vaccination (within 21 days) or any non-live vaccine (within 14 days)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of treatment-emergent adverse events measured using data collected from electronic Case Report Forms (eCRF) from Screening through to Day 57, Day 71, or final follow-up visit 2. Number of injection site reactions measured using data collected from electronic Case Report Forms (eCRF) from Baseline through to Day 4 and Day 15 to Day 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum Observed Plasma Concentration (Cmax) will be assessed by measuring the concentration of study compounds in blood samples collected from Baseline through to Day 57 (excluding Day 14), Day 71, or the final follow-up visit 2. Time to Maximum Observed Concentration (Tmax) will be assessed by determining the time at which the highest concentration of study compounds occurs in blood samples collected from Baseline through to Day 57 (excluding Day 14), Day 71, or the final follow-up visit 3. Area Under the Curve (AUC) will be assessed by calculating the total exposure to the study compounds over time using blood samples collected from Baseline through to Day 57 (excluding Day 14), Day 71, or the final follow-up visit 4. Half-Life (T1/2) will be assessed by estimating the time required for the concentration of study compounds in the blood to decrease by half, based on samples collected from Baseline through to Day 57 (excluding Day 14), Day 71, or the final follow-up visit 5. Measurement of Immunoglobulins and changes over time measured using laboratory testing from Baseline through to Day 57 (except Day 14), Day 71, or final follow-up visit 6. Level of APRIL Measurement of APRIL in pg/mL and changes over time measured using laboratory testing on Day -1, Baseline, Day 1, Day 4, Day 8, Day 14, Day 15, Day 17, Day 18, Day 22, Day 29, Day 57, final follow-up visit 7. Immunogenicity Measurement of CLYM116 antidrug antibodies (ADA) measured using laboratory testing at Baseline, Day 15, Day 29, Day 43, Day 57, Day 71, final follow-up visit | — |
Countries
Australia
Contacts
Public ContactStefan Beeck
Outcome results
None listed