Phase 1 Safety Study of ALRN-5281 in Healthy Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Growth Hormone Deficiency
In brief
The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.
Key facts
- Study ID
- NCT01775358
- Run by
- Aileron Therapeutics, Inc.
- People needed
- 33
- Starts
- 2013-01-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2013-05-30
Who can join
Age: 20 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent.
- Subjects must be in good health as determined by the Investigator based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ECGs and other screening evaluations.
- Ability to provide written informed consent and complying with all study requirements and restrictions.
- Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening
You may not qualify if…
- History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator
- Previous treatment with any GH Releasing Hormone (GHRH) analog.
- Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
- History of cancer within the past five years (excluding non-melanoma skin cancer).
- History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
- Subjects with a body weight > 120 kg.
Where it is running
- Vince and Associates Clinical Research, LLC — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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