A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | Skin and Soft Tissue Infections |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 11/16/2018 |
Start Date: | August 12, 2013 |
End Date: | January 7, 2014 |
A Phase 1, Double-Blind, Single Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 (Recombinant Fully Human Antibody Inhibitor of Plasma Kallikrein) in Healthy Subjects
The purpose of this study is to assess the safety and tolerability of the study drug
(DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to
receive DX-2930 or placebo.
(DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to
receive DX-2930 or placebo.
Approximately 32 healthy subjects will be randomized to receive DX-2930 or placebo.
Inclusion Criteria:
1. Male or female subjects who are 18 to 55 years of age, inclusive.
2. Willing and able to read, understand, and sign an informed consent form.
3. Willing and able to receive subcutaneous injections.
4. Body mass index (BMI) of 18 to 33 kg/m2 with a weight of at least 60 kg for males and
at least 50 kg for females, with a maximum weight of 130 kg for any subject.
5. Medically healthy as determined by the investigator via assessment of physical
examination, medical history, clinical laboratory tests, vital signs, and
electrocardiogram (ECG).
6. Females of childbearing potential must agree to be abstinent or else use any two of
the following medically acceptable forms of contraception from the Screening Period
through 30 days after the final study visit: condom with spermicidal jelly, diaphragm
or cervical cap with spermicidal jelly, or intra-uterine device (IUD). A female whose
male partner has had a vasectomy must agree to use one additional form of medically
acceptable contraception. Female subjects must agree to practice the above birth
control methods for 30 days after the final study visit as a safety precaution.
7. Females of non-childbearing potential, defined as surgically sterile (status post
hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal
for at least 12 months (and confirmed with a screening follicle-stimulating hormone
(FSH) level in the post-menopausal range), do not require contraception during the
study.
8. Males with female partners of childbearing potential must agree to use a highly
effective, medically acceptable form of contraception from the screening period
through 60 days after the final study visit. All male subjects, including males who
are surgically sterile (post vasectomy), must agree to practice the above birth
control methods for 60 days from the final study visit as a safety precaution.
Exclusion Criteria:
1. Any active acute or chronic illness at screening.
2. Any history of exposure to a biologic within 90 days prior to dosing.
3. Receipt of any investigational (a non-licensed, non-approved) drug or device within 60
days prior to dosing.
4. Any prior history of exposure to a monoclonal antibody.
5. Pregnant or actively breastfeeding.
6. Any history of substance abuse or dependence.
7. Positive urine drug or alcohol test at screening or Day -1 for amphetamines,
benzodiazepines, barbiturates, cocaine, cotinine (detection mechanism for nicotine),
marijuana, opiates, phencyclidine or ethanol.
8. Regular use of alcohol within six months prior to the screening visit [more than
fourteen units of alcohol per week (1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL
of 40% alcohol)].
9. Use of prescription or over-the-counter medication within 14 days prior to
administration of study medication, or use of over-the-counter products (dietary or
herbal supplements and vitamins) within 14 days prior to administration of study
medication.
10. Use of nicotine or nicotine-containing products within the previous three months prior
to screening.
11. Subject has any other condition, which in the opinion of the investigator may
compromise the safety or compliance or would preclude the subject from successful
completion of the study or interfere with the interpretation of the results.
12. Abnormal clinical laboratory values and/or other study assessments such as ECG results
deemed to be clinically significant by the investigator.
13. Donation of blood within 60 days preceding Study Day -1.
14. Serology testing positive for hepatitis B surface antigen (HBsAg), hepatitis C virus
(HCV), or human immunodeficiency virus (HIV).
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