HealthyPhase 1NCT05481333
A Trial to Learn if REGN7999 is Safe and Well Tolerated, and How it Works in the Body of Healthy Participants
A Phase 1 study testing REGN7999 in people with Healthy, run by Regeneron Pharmaceuticals at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- REGN7999
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Oct 2022to 29 Aug 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has a body mass index between 18 and 32 kg/m2, inclusive
- 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
- Is in good health based on laboratory safety testing obtained at the screening and baseline visits per the protocol
- 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
- 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
Who cannot join
- 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:
- 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;
- intra-uterine device (IUD); intra-uterine hormone-releasing system;
- bilateral tubal ligation or tubal occlusion;
- 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
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- sexual abstinence as described in the protocol
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7999, a TMPRSS6 Antagonist, in Healthy Adult Subjects
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
- Conditions
- Healthy
- Being tested
- REGN7999, Placebo
- Keywords
- Non-menstruating, Transmembrane protease, serine 6 (TMPRSS6) antagonist, First in Human (FIH), Human monoclonal antibody (mAb)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN7999Drug
Ascending IV or SC dose administered per protocol
PlaceboDrug
Ascending IV or SC dose administered per protocol
| Study group | Role | What they receive |
|---|---|---|
| IV Cohort 1 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 Receives: Drug: REGN7999; Drug: Placebo |
| IV Cohort 2 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 Receives: Drug: REGN7999; Drug: Placebo |
| IV Cohort 3 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 Receives: Drug: REGN7999; Drug: Placebo |
| IV Cohort 4 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 Receives: Drug: REGN7999; Drug: Placebo |
| IV Cohort 5 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 Receives: Drug: REGN7999; Drug: Placebo |
| SC Cohort 1 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 Receives: Drug: REGN7999; Drug: Placebo |
| SC Cohort 2 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 Receives: Drug: REGN7999; Drug: Placebo |
| SC Cohort 3 | Experimental | Single dose REGN7999 or Placebo; randomized 3:1 Receives: Drug: REGN7999; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through the end of study visit, week 26
Secondary outcomes (4)
Concentrations of REGN7999 in serum
IV cohorts 1 to 4 for SC cohorts 1 and 2
Measured: Through the end of study visit, week 20
Concentrations of REGN7999 in serum
IV cohort 5 and SC cohort 3
Measured: 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
Measured: 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
Measured: Through the end of study visit, week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start24 Oct 2022
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 64 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
- NCT05481333
- Sponsor's protocol ID
- R7999-HV-2154
- Other IDs
- 2022-500398-15-00
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2022
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7999, a TMPRSS6 Antagonist, in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05481333
- Acronym / sponsor ID
- R7999-HV-2154
- Conditions
- Healthy
- Keywords
- Non-menstruating, Transmembrane protease, serine 6 (TMPRSS6) antagonist, First in Human (FIH), Human monoclonal antibody (mAb)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 1 Aug 2022 (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.
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
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 | Experimental | Drug: REGN7999, Drug: PlaceboSingle dose REGN7999 or Placebo; randomized 3:1 |
| IV Cohort 2 | Experimental | Drug: REGN7999, Drug: PlaceboSingle dose REGN7999 or Placebo; randomized 3:1 |
| IV Cohort 3 | Experimental | Drug: REGN7999, Drug: PlaceboSingle dose REGN7999 or Placebo; randomized 3:1 |
| IV Cohort 4 | Experimental | Drug: REGN7999, Drug: PlaceboSingle dose REGN7999 or Placebo; randomized 3:1 |
| IV Cohort 5 | Experimental | Drug: REGN7999, Drug: PlaceboSingle dose REGN7999 or Placebo; randomized 3:1 |
| SC Cohort 1 | Experimental | Drug: REGN7999, Drug: PlaceboSingle dose REGN7999 or Placebo; randomized 3:1 |
| SC Cohort 2 | Experimental | Drug: REGN7999, Drug: PlaceboSingle dose REGN7999 or Placebo; randomized 3:1 |
| SC Cohort 3 | Experimental | Drug: REGN7999, Drug: PlaceboSingle dose REGN7999 or Placebo; randomized 3:1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Has a body mass index between 18 and 32 kg/m2, inclusive
- 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
- Is in good health based on laboratory safety testing obtained at the screening and baseline visits per the protocol
- 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
- 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 (15 listed)
- 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.
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 |
|---|---|---|
| REGN7999Ascending IV or SC dose administered per protocol | Drug | IV Cohort 1, IV Cohort 2, IV Cohort 3, IV Cohort 4, IV Cohort 5, SC Cohort 1, SC Cohort 2, SC Cohort 3 |
| PlaceboAscending IV or SC dose administered per protocol | Drug | IV Cohort 1, IV Cohort 2, IV Cohort 3, IV Cohort 4, IV Cohort 5, SC Cohort 1, SC Cohort 2, SC Cohort 3 |
Primary outcome
Incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with REGN7999 or placebo
Time frame: Through the end of study visit, week 20
IV cohorts 1 to 4 SC cohorts 1 and 2
Incidence and severity of TEAEs in participants treated with REGN7999 or placebo
Time frame: Through the end of study visit, week 26
IV cohort 5 and SC cohort 3
4 secondary outcomes
Concentrations of REGN7999 in serum
Time frame: Through the end of study visit, week 20
Concentrations of REGN7999 in serum
Time frame: Through the end of study visit, week 26
Incidences of anti-drug antibodies (ADA) to REGN7999 over time
Time frame: Through the end of study visit, week 20
Incidences of anti-drug antibodies (ADA) to REGN7999 over time
Time frame: Through the end of study visit, week 26
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 24 Jul 2024.
- 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 REGN7999 in people with Healthy, run by Regeneron Pharmaceuticals at 1 site in Belgium.
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 5 inclusion and 15 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 24 Jul 2024. 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 Belgium. 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 and severity of treatment emergent adverse events (TEAEs) in participants treated with REGN7999 or placebo (time frame: Through the end of study visit, week 20). 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 24 Jul 2024.