A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorClimb Bio, Inc.
About this trial
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CLYM116
- Placebo
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov