Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • CLYM116

    Drug

    CLYM116 to be administered by SC injection

  • Placebo

    Drug

    Placebo solution to be administered at a matching volume by SC injection

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: CLYM116Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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 outcomes

1

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
2

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
3

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.
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Climb Bio, Inc.

Lead sponsor

Source ClinicalTrials.gov
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