A Study to See How Safe and Tolerable Different Doses of REGN13335 Are When Administered Intravenously (IV) or Subcutaneously (SC) to Healthy Adult Participants

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06137482
• Other study ID #: R13335-HV-2289
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 6, 2023
• Est. completion date: September 12, 2024

Study information

• Verified date: May 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: September 12, 2024
• Est. primary completion date: September 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

1. Has a body mass index between 18 and 32 kg/m^2, inclusive, at the screening visit

2. 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:

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• REGN13335
Administered intravenous (IV) or subcutaneous (SC), sequential ascending single dose
• Matching Placebo
Administered IV or SC, sequential ascending single dose

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research	Christchurch	Canterbury

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events (TEAE's) through the end of the study (EOS)		Baseline to day 113
Primary	Severity of TEAE's through the EOS		Baseline to day 113
Secondary	Concentrations of functional REGN13335 in plasma through the EOS visit		Baseline to day 113
Secondary	Incidence of anti-drug antibodies (ADA) to single doses of REGN13335 over time		Baseline to day 113
Secondary	Titer of ADA to single doses of REGN13335 over time		Baseline to day 113