Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

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Brief Title

Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

Official Title

A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of ALRN-5281 Administered by Subcutaneous Injection in Healthy Adult Volunteers

Brief Summary

      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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence of adverse events

Secondary Outcome

 Serum IGF-1

Condition

Growth Hormone Deficiency

Intervention

ALRN-5281 0.015 mg/kg

Study Arms / Comparison Groups

 ALRN-5281 0.015 mg/kg
Description:  Dosage-0.015 mg/kg

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

33

Start Date

January 2013

Completion Date

May 2013

Primary Completion Date

May 2013

Eligibility Criteria

        Inclusion Criteria:

          1. Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of
             informed consent.

          2. 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.

          3. Ability to provide written informed consent and complying with all study requirements
             and restrictions.

          4. Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening

        Exclusion Criteria:

          1. 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

          2. Previous treatment with any GH Releasing Hormone (GHRH) analog.

          3. Participation in another clinical trial or treatment with an investigational agent
             within 30 days or 5 half-lives, whichever is longer, prior to enrollment.

          4. History of cancer within the past five years (excluding non-melanoma skin cancer).

          5. History of alcohol or drug abuse or dependence within 12 months of screening as
             determined by the Investigator.

          6. Subjects with a body weight > 120 kg.
      

Gender

All

Ages

20 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Bradley D Vince, D.O., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01775358

Organization ID

ALRN-100-01


Responsible Party

Sponsor

Study Sponsor

Aileron Therapeutics, Inc.


Study Sponsor

Bradley D Vince, D.O., Principal Investigator, Vince and Associates


Verification Date

May 2013