A Phase 1 Study of CLYM116 in Normal Healthy Volunteers

February 19, 2026 updated by: Climb Bio, Inc.

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

This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Brisbane, Australia, 4006
        • Recruiting
        • Nucleus Network Brisbane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subcutaneous (SC) injection of placebo
Drug: Placebo
Placebo solution to be administered at a matching volume by SC injection
Experimental: CLYM116
Subcutaneous (SC) injection of CLYM116
Drug: CLYM116
CLYM116 to be administered by SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of injection site reactions Number of injection site reactions
Time Frame: From Baseline through to Day 4 and Day 15 to Day 18
From Baseline through to Day 4 and Day 15 to Day 18
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
From Screening through to Day 85, or final follow-up visit

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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.
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
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
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
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
Baseline, Day 15, Day 29, Day 43, Day 71, Day 85, follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Climb Bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLYM116-NHV-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe