A Phase 1 interventional study of REGN7999 and Placebo in Healthy, sponsored by Regeneron Pharmaceuticals. Completed at 1 site in Belgium. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment
The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN7999 in healthy adult participants.
The secondary objectives of the study are:
Regeneron Pharmaceuticals is the lead sponsor of 410 studies on the registry; 93 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 79 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Consistent with Clinical Trial Facilitation Group (CTFG) guidance, women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception, during the study through the end of study (EOS) visit. Highly effective contraceptive measures include:
Note: Other protocol-defined Inclusion and Exclusion Criteria apply
Single dose REGN7999 or Placebo; randomized 3:1
Drug: REGN7999 · Drug: Placebo
Single dose REGN7999 or Placebo; randomized 3:1
Drug: REGN7999 · Drug: Placebo
Single dose REGN7999 or Placebo; randomized 3:1
Drug: REGN7999 · Drug: Placebo
Single dose REGN7999 or Placebo; randomized 3:1
Drug: REGN7999 · Drug: Placebo
Single dose REGN7999 or Placebo; randomized 3:1
Drug: REGN7999 · Drug: Placebo
Single dose REGN7999 or Placebo; randomized 3:1
Drug: REGN7999 · Drug: Placebo
Single dose REGN7999 or Placebo; randomized 3:1
Drug: REGN7999 · Drug: Placebo
Single dose REGN7999 or Placebo; randomized 3:1
Drug: REGN7999 · Drug: Placebo
Ascending IV or SC dose administered per protocol
Ascending IV or SC dose administered per protocol
Incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with REGN7999 or placebo
IV cohorts 1 to 4 SC cohorts 1 and 2
Time frame: Through the end of study visit, week 20
Incidence and severity of TEAEs in participants treated with REGN7999 or placebo
IV cohort 5 and SC cohort 3
Time frame: Through the end of study visit, week 26
Concentrations of REGN7999 in serum
IV cohorts 1 to 4 for SC cohorts 1 and 2
Time frame: Through the end of study visit, week 20
Concentrations of REGN7999 in serum
IV cohort 5 and SC cohort 3
Time frame: Through the end of study visit, week 26
Incidences of anti-drug antibodies (ADA) to REGN7999 over time
IV cohorts 1 to 4 for SC cohorts 1 and 2
Time frame: Through the end of study visit, week 20
Incidences of anti-drug antibodies (ADA) to REGN7999 over time
IV cohort 5 and SC cohort 3
Time frame: Through the end of study visit, week 26
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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