NCT07248865

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
4mo left

Started Dec 2025

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Dec 2025Sep 2026

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 2, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

November 18, 2025

Last Update Submit

February 19, 2026

Conditions

Healthy Volunteers

Keywords

CLYM116APRILmonoclonal antibodyhealthy volunteersPhase 1IgA nephropathyMIL116

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability of single and multiple ascending doses of CLYM116 in healthy volunteers Incidence of treatment-emergent adverse events

    From Screening through to Day 85, or final follow-up visit

  • Incidence of injection site reactions Number of injection site reactions

    From Baseline through to Day 4 and Day 15 to Day 18

Secondary Outcomes (7)

  • Maximum Observed Plasma Concentration (Cmax) Measurement of the maximum observed plasma concentration.

    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.

    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.

    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

    From Baseline through to Day 85 (except Day 14), or final follow-up visit

  • Levels of Immunoglobulins Measurement of Immunoglobulins and changes over time

    From Screening through to Day 85, or final follow-up visit

  • +2 more secondary outcomes

Study Arms (2)

CLYM116

EXPERIMENTAL

Subcutaneous (SC) injection of CLYM116

Drug: CLYM116

Placebo

PLACEBO COMPARATOR

Subcutaneous (SC) injection of placebo

Drug: Placebo

Interventions

CLYM116DRUG

CLYM116 to be administered by SC injection

CLYM116
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network Brisbane

Brisbane, 4006, Australia

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Climb Bio Study Director

CONTACT

+1 866 857 2596clinicaltrials@climbbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

December 2, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)