Healthy VolunteersPhase 1NCT06137482
A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants
A Phase 1 study testing REGN13335 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in New Zealand.
Trial summary
This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults. The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN13335
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteNew Zealand
- Study dates
- 6 Dec 2023to 11 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a body mass index between 18 and 32 kg/m^2, inclusive, at the screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety tests, and electrocardiograms (ECGs) performed prior to administration of study drug (ie, screening and baseline visit)
Who cannot join
- 1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator
- NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
New Zealand Clinical Research
Christchurch, Canterbury, 8011
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN13335, a Platelet-Derived Growth Factor-B Antagonist, in Healthy Adult Participants
This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults.
The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is present in the blood of study participants at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
- Conditions
- Healthy Volunteers
- Being tested
- REGN13335, Matching Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN13335Drug
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
Matching PlaceboDrug
Administered IV or SC, sequential ascending single dose
| Study group | Role | What they receive |
|---|---|---|
| IV Cohort 1 Low Dose | Experimental | Randomized as described in the protocol Receives: Drug: REGN13335; Drug: Matching Placebo |
| IV Cohort 2 Mid Dose | Experimental | Randomized as described in the protocol Receives: Drug: REGN13335; Drug: Matching Placebo |
| IV Cohort 3 High Dose | Experimental | Randomized as described in the protocol Receives: Drug: REGN13335; Drug: Matching Placebo |
| IV Cohort 4 Higher Dose | Experimental | Randomized as described in the protocol Receives: Drug: REGN13335; Drug: Matching Placebo |
| IV Cohort 5 Highest Dose | Experimental | Randomized as described in the protocol Receives: Drug: REGN13335; Drug: Matching Placebo |
| SC Cohort 1 Low Dose | Experimental | Randomized as described in the protocol Receives: Drug: REGN13335; Drug: Matching Placebo |
| SC Cohort 2 High Dose | Experimental | Randomized as described in the protocol Receives: Drug: REGN13335; Drug: Matching Placebo |
| IV or SC Optional Cohort | Experimental | ≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol Receives: Drug: REGN13335; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit
Measured: Baseline to day 113
Severity of TEAE's through the EOS visit
Measured: Baseline to day 113
Secondary outcomes (3)
Concentrations of functional REGN13335 in plasma through the EOS visit
Measured: Baseline to day 113
Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time
Measured: Baseline to day 113
Titer of ADA to single doses of REGN13335 over time
Measured: Baseline to day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start6 Dec 2023
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
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.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137482
- Sponsor's protocol ID
- R13335-HV-2289
- Status last verified
- Mar 2025
- First submitted
- 13 Nov 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenously or Subcutaneously Administered REGN13335, a Platelet-Derived Growth Factor-B Antagonist, in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06137482
- Acronym / sponsor ID
- R13335-HV-2289
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 18 Nov 2023 (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 study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults.
The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is present in the blood of study participants at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| IV Cohort 1 Low Dose | Experimental | Drug: REGN13335, Drug: Matching PlaceboRandomized as described in the protocol |
| IV Cohort 2 Mid Dose | Experimental | Drug: REGN13335, Drug: Matching PlaceboRandomized as described in the protocol |
| IV Cohort 3 High Dose | Experimental | Drug: REGN13335, Drug: Matching PlaceboRandomized as described in the protocol |
| IV Cohort 4 Higher Dose | Experimental | Drug: REGN13335, Drug: Matching PlaceboRandomized as described in the protocol |
| IV Cohort 5 Highest Dose | Experimental | Drug: REGN13335, Drug: Matching PlaceboRandomized as described in the protocol |
| SC Cohort 1 Low Dose | Experimental | Drug: REGN13335, Drug: Matching PlaceboRandomized as described in the protocol |
| SC Cohort 2 High Dose | Experimental | Drug: REGN13335, Drug: Matching PlaceboRandomized as described in the protocol |
| IV or SC Optional Cohort | Experimental | Drug: REGN13335, Drug: Matching Placebo≤ Highest IV or SC Dose as described in the protocol Randomized as described in the protocol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has a body mass index between 18 and 32 kg/m^2, inclusive, at the screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, laboratory safety tests, and electrocardiograms (ECGs) performed prior to administration of study drug (ie, screening and baseline visit)
Key exclusion criteria (2 listed)
- 1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator
- NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
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 |
|---|---|---|
| REGN13335Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose | Drug | IV Cohort 1 Low Dose, IV Cohort 2 Mid Dose, IV Cohort 3 High Dose, IV Cohort 4 Higher Dose, IV Cohort 5 Highest Dose, IV or SC Optional Cohort, SC Cohort 1 Low Dose, SC Cohort 2 High Dose |
| Matching PlaceboAdministered IV or SC, sequential ascending single dose | Drug | IV Cohort 1 Low Dose, IV Cohort 2 Mid Dose, IV Cohort 3 High Dose, IV Cohort 4 Higher Dose, IV Cohort 5 Highest Dose, IV or SC Optional Cohort, SC Cohort 1 Low Dose, SC Cohort 2 High Dose |
Primary outcome
Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit
Time frame: Baseline to day 113
Severity of TEAE's through the EOS visit
Time frame: Baseline to day 113
3 secondary outcomes
Concentrations of functional REGN13335 in plasma through the EOS visit
Time frame: Baseline to day 113
Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time
Time frame: Baseline to day 113
Titer of ADA to single doses of REGN13335 over time
Time frame: Baseline to day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
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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. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
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 REGN13335 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 1 site in New Zealand.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 19 Mar 2025. 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 New Zealand. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS) visit (time frame: Baseline to day 113). 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 19 Mar 2025.