Phase
Condition
N/ATreatment
Placebo
Injectafer
Clinical Study ID
Ages 18-40 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Man or woman, age 18-40 years
BMI 18.5-30 kg/m2
In good health as determined by the Office of Medical Support & Oversight (OMSO) General Medical Clearance
Passed his/her most recent Army Combat Fitness Test (ACFT) (Military VolunteersOnly) or exercises at least 2 times per week and able to complete two mile runin ≤ 21 minutes (Civilian Volunteers)
Willing to not exercise, or drink alcoholic/caffeinated beverages 24 hoursprior to each testing session
Willing to not perform any strenuous exercise 36 hours prior to each testingsession
Exclusion
Exclusion Criteria:
Women who are pregnant or planning to become pregnant during the study
Taking prescription medication, or over-the-counter medications other thancontraceptives, unless approved by OMSO & PI
Taking dietary supplements unless approved by OMSO & PI
Born at altitudes greater than 2,100 m (7,000 ft)
Living in areas that are more than 1,200 m (4,000 ft) or have traveled to areasthat are more than 1,200 m for five days or more within the last 2 months
Prior diagnosis of High Altitude Pulmonary Edema (HAPE) or High AltitudeCerebral Edema (HACE)
Musculoskeletal injuries that compromise the ability to walk/run on a treadmill
Presence of abnormal blood chemicals (hemoglobin S or Sickle Cell Trait)
Hemoglobin concentration: men: Hb <13.5 g/dL or Hb >17.7 g/dL; women Hb <12.5g/dL or Hb >15.9 g/dL
Ferritin < 50 ng/mL or greater than 150 ng/mL
Any history of malignancy
Personal or family history of blood clots
History of thromboembolic disease, hypertension, and known risk factors ofcardiovascular disease
Blood donation within 8 weeks of beginning the study
History of seizures
History of inflammatory bowel disease
Any recent (within 4-6 weeks) and or expected history of prolonged periods ofimmobility or limited activity (including recent or upcoming surgery)
Abnormal PT/PTT test or problems with blood clotting
Any nicotine or recreational drug use (unless quit > 1 month prior to studyorientation)
Presence of respiratory tract infections (< 1 month prior)
Experience recent cold, coughs, or sinus infections (< 2 weeks prior)
Allergy to skin adhesive
Evidence of apnea or sleeping disorder
Present condition of alcoholism, use of anabolic steroids, other substanceabuse issues
Body mass <50 kg (110.5 lbs)
History of hyperparathyroidism
History of vitamin D deficiency
History of systemic inflammatory disease (rheumatoid arthritis, lupuserythematosus)
Any drug allergies
History of hypersensitivity reaction
History of asthma
History of kidney or liver disease
Any previous intravenous iron injection
Study Design
Study Description
Connect with a study center
USARIEM
Natick, Massachusetts 01760
United StatesActive - Recruiting

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