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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-500398-15-00 | Other Identifier | EUCT Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Cohort 1 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 |
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| IV Cohort 2 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 |
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| IV Cohort 3 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 |
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| IV Cohort 4 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 |
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| IV Cohort 5 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 |
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| SC Cohort 1 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7999 | Drug | Ascending IV or SC dose administered per protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Through the end of study visit, week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of REGN7999 in serum | IV cohorts 1 to 4 for SC cohorts 1 and 2 | Through the end of study visit, week 20 |
| Concentrations of REGN7999 in serum | IV cohort 5 and SC cohort 3 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Pregnant or breastfeeding women
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:
In addition, premenopausal women whose method(s) of birth control is/are associated with ongoing menstruation (eg, combined hormonal contraceptive regimens associated with withdrawal bleeding, non-hormone-releasing IUD, bilateral tubal ligation, bilateral salpingectomy, vasectomized partner, sexual abstinence). Female participants must not be menstruating during the trial, due to being postmenopausal or due to permanent sterilization via hysterectomy, and/or bilateral oophorectomy, or amenorrheic due to use of hormone-releasing IUD, implantable device, or intake of continuous hormonal contraception
Sexually active male participants with WOCBP partners who are unwilling to use the following forms of medically acceptable birth control during the study through the EOS visit: vasectomy with medical assessment of surgical success OR consistent use of a condom
History of clinically significant cardiovascular (including congestive heart failure and angina), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, infectious, autoimmune, oncologic, psychiatric or neurological disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation.
History of chronic anemia, at any time in the past
History of RBC transfusion reaction
Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to screening. Planning on whole blood or plasma donation at any time point during the study.
Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or nonprescription drugs or food
Note: Other protocol-defined Inclusion and Exclusion Criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Drug Research Unit Gent | Ghent | 9000 | Belgium |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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.
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
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| SC Cohort 2 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 |
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| SC Cohort 3 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 |
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| Placebo | Drug | Ascending IV or SC dose administered per protocol |
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| 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 | 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 | Through the end of study visit, week 26 |