A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CLYM116, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose (SAD) and Multiple-Ascending-Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injection(s) of CLYM116 in Normal Healthy Volunteers
Overview
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
- Drug CLYM116
CLYM116 to be administered by SC injection - Drug Placebo
Placebo solution to be administered at a matching volume by SC injection
Primary outcome measures
- Safety and tolerability of single and multiple ascending doses of CLYM116 in healthy volunteers Incidence of treatment-emergent adverse events [Time frame: From Screening through to Day 85, or final follow-up visit]
- Incidence of injection site reactions Number of injection site reactions [Time frame: From Baseline through to Day 4 and Day 15 to Day 18]
Secondary outcome measures (7)
- Maximum Observed Plasma Concentration (Cmax) Measurement of the maximum observed plasma concentration. [Time frame: 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. [Time frame: 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. [Time frame: 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 [Time frame: From Baseline through to Day 85 (except Day 14), or final follow-up visit]
- Levels of Immunoglobulins Measurement of Immunoglobulins and changes over time [Time frame: From Screening through to Day 85, or final follow-up visit]
- Level of APRIL Measurement of APRIL in pg/mL and changes over time [Time frame: 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) [Time frame: Baseline, Day 15, Day 29, Day 43, Day 71, Day 85, follow-up visit]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Australia · 1 center
- Nucleus Network Brisbane — Brisbane
Identifiers
NCT: NCT07248865 · CLYM116-NHV-101