Healthy VolunteersPhase 1NCT07248865
A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
A Phase 1 study testing CLYM116 in people with Healthy Volunteers, run by Climb Bio, Inc. at 1 site in Australia.
Trial summary
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CLYM116
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Dec 2025to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network Brisbane
Brisbane, 4006
About this study
Official 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
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- CLYM116, Placebo
- Keywords
- CLYM116, APRIL, monoclonal antibody, healthy volunteers, Phase 1, IgA nephropathy, MIL116
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLYM116Drug
CLYM116 to be administered by SC injection
PlaceboDrug
Placebo solution to be administered at a matching volume by SC injection
| Study group | Role | What they receive |
|---|---|---|
| CLYM116 | Experimental | Subcutaneous (SC) injection of CLYM116 Receives: Drug: CLYM116 |
| Placebo | Placebo comparator | Subcutaneous (SC) injection of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single and multiple ascending doses of CLYM116 in healthy volunteers Incidence of treatment-emergent adverse events
Measured: From Screening through to Day 85, or final follow-up visit
Incidence of injection site reactions Number of injection site reactions
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From Baseline through to Day 85 (except Day 14), or final follow-up visit
Levels of Immunoglobulins Measurement of Immunoglobulins and changes over time
Measured: From Screening through to Day 85, or final follow-up visit
Level of APRIL Measurement of APRIL in pg/mL and changes over time
Measured: 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)
Measured: Baseline, Day 15, Day 29, Day 43, Day 71, Day 85, follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start2 Dec 2025
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Climb Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248865
- Sponsor's protocol ID
- CLYM116-NHV-101
- Status last verified
- Feb 2026
- First submitted
- 18 Nov 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07248865
- Acronym / sponsor ID
- CLYM116-NHV-101
- Conditions
- Healthy Volunteers
- Keywords
- CLYM116, APRIL, monoclonal antibody, healthy volunteers, Phase 1, IgA nephropathy, MIL116
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Climb Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLYM116 | Experimental | Drug: CLYM116Subcutaneous (SC) injection of CLYM116 |
| Placebo | Placebo comparator | Drug: PlaceboSubcutaneous (SC) injection of placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLYM116CLYM116 to be administered by SC injection | Drug | CLYM116 |
| PlaceboPlacebo solution to be administered at a matching volume by SC injection | Drug | Placebo |
Primary outcome
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
Incidence of injection site reactions Number of injection site reactions
Time frame: From Baseline through to Day 4 and Day 15 to Day 18
7 secondary outcomes
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
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
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.
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
Levels of Immunoglobulins Measurement of Immunoglobulins and changes over time
Time frame: 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
Immunogenicity Measurement of CLYM116 antidrug antibodies (ADA)
Time frame: Baseline, Day 15, Day 29, Day 43, Day 71, Day 85, follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLYM116 in people with Healthy Volunteers, run by Climb Bio, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Climb Bio Study Director (+1 866 857 2596, clinicaltrials@climbbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.