A Trial to Learn if REGN7999 is Safe and Well Tolerated, and How it Works in the Body of Healthy … (NCT05481333) | Clinical Trial Compass
CompletedPhase 1
A Trial to Learn if REGN7999 is Safe and Well Tolerated, and How it Works in the Body of Healthy Participants
Belgium64 participantsStarted 2022-10-24
Plain-language 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
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
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:
✕. 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;
✕
What they're measuring
1
Incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with REGN7999 or placebo
Timeframe: Through the end of study visit, week 20
2
Incidence and severity of TEAEs in participants treated with REGN7999 or placebo
Timeframe: Through the end of study visit, week 26
✕. 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
✕. 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