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NCT Number: NCT07248865

A Phase 1 Study 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.

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Key information

Conditions

Healthy Volunteers Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network Brisbane

Brisbane, 4006, Australia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CLYM116

Drug

CLYM116 to be administered by SC injection

Placebo

Drug

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

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

  5. Levels of Immunoglobulins Measurement of Immunoglobulins and changes over time

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

  6. 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

  7. Immunogenicity Measurement of CLYM116 antidrug antibodies (ADA)

    Time frame: Baseline, Day 15, Day 29, Day 43, Day 71, Day 85, follow-up visit

Study contacts

Contact information is provided by the study sponsor or research team.

Climb Bio Study Director

CONTACT

[email protected]

+1 866 857 2596

Sponsors and collaborators

Lead sponsor

Climb Bio, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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