ClinicalTrials.gg
CompletedNCT05481333Updated Jul 24, 2024

A Trial to Learn if REGN7999 is Safe and Well Tolerated, and How it Works in the Body of Healthy Participants

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

Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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:

  • To characterize the drug concentration profile of single doses of IV or SC REGN7999
  • To assess the immunogenicity of single ascending SC or IV doses of REGN7999
02

Conditions studied

  • Healthy

Keywords

  • Non-menstruating
  • Transmembrane protease, serine 6 (TMPRSS6) antagonist
  • First in Human (FIH)
  • Human monoclonal antibody (mAb)
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  1. Has a body mass index between 18 and 32 kg/m2, inclusive
  2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram (ECG)s performed at screening and/or prior to administration of initial dose of study drug
  3. Is in good health based on laboratory safety testing obtained at the screening and baseline visits per the protocol
  4. Hemoglobin, serum iron, transferrin, serum ferritin, and transferrin saturation, equal to or above the lower limit of the reference range for the participant's age and sex at the local labs, at screening, repeatable once during screening period
  5. White blood cell (WBC) count, platelet count, red blood cell (RBC) count, hematocrit, and RBC hemoglobin not clinically significantly outside of the reference range in the judgment of the investigator at screening and baseline visits

Key Exclusion Criteria:

  1. Pregnant or breastfeeding women
  2. 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:

    1. stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;
    2. intra-uterine device (IUD); intra-uterine hormone-releasing system;
    3. bilateral tubal ligation or tubal occlusion;
    4. vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and/or
    5. sexual abstinence as described in the protocol
  3. 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
  4. 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
  5. 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.
  6. History of chronic anemia, at any time in the past
  7. History of RBC transfusion reaction
  8. 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.
  9. 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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    IV Cohort 1

    Single dose REGN7999 or Placebo; randomized 3:1

    Drug: REGN7999 · Drug: Placebo

  • Experimental
    IV Cohort 2

    Single dose REGN7999 or Placebo; randomized 3:1

    Drug: REGN7999 · Drug: Placebo

  • Experimental
    IV Cohort 3

    Single dose REGN7999 or Placebo; randomized 3:1

    Drug: REGN7999 · Drug: Placebo

  • Experimental
    IV Cohort 4

    Single dose REGN7999 or Placebo; randomized 3:1

    Drug: REGN7999 · Drug: Placebo

  • Experimental
    IV Cohort 5

    Single dose REGN7999 or Placebo; randomized 3:1

    Drug: REGN7999 · Drug: Placebo

  • Experimental
    SC Cohort 1

    Single dose REGN7999 or Placebo; randomized 3:1

    Drug: REGN7999 · Drug: Placebo

  • Experimental
    SC Cohort 2

    Single dose REGN7999 or Placebo; randomized 3:1

    Drug: REGN7999 · Drug: Placebo

  • Experimental
    SC Cohort 3

    Single dose REGN7999 or Placebo; randomized 3:1

    Drug: REGN7999 · Drug: Placebo

Interventions

  • DrugREGN7999

    Ascending IV or SC dose administered per protocol

  • DrugPlacebo

    Ascending IV or SC dose administered per protocol

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. Concentrations of REGN7999 in serum

    IV cohort 5 and SC cohort 3

    Time frame: Through the end of study visit, week 26

  3. 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

  4. 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

07

Study locations

1 site
  • Drug Research Unit Gent
    Ghent, 9000, Belgium
08

References and documents

Individual participant data

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05481333
Responsible party
Sponsor
First posted
Aug 1, 2022
Start date
Oct 24, 2022
Primary completion
Aug 29, 2023
Completion
Aug 29, 2023
Last update
Jul 24, 2024

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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