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Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01775358
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
Aileron Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: ALRN-5281 0.015 mg/kg Drug: ALRN-5281 0.05 mg/kg Drug: ALRN-5281 0.15 mg/kg Drug: Placebo 0.015 mg/kg Drug: Placebo 0.05mg/kg Drug: Placebo 0.15mg/kg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : January 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: ALRN-5281 0.015 mg/kg
Dosage-0.015 mg/kg
Drug: ALRN-5281 0.015 mg/kg
Experimental: ALRN-5281 0.05 mg/kg
Dosage- 0.05 mg/kg
Drug: ALRN-5281 0.05 mg/kg
Experimental: ALRN-5281 0.15 mg/kg
Dosage- 0.15 mg/kg
Drug: ALRN-5281 0.15 mg/kg
Placebo Comparator: Placebo 0.015 mg/kg
Dosage- 0.015 mg/kg
Drug: Placebo 0.015 mg/kg
Placebo Comparator: Placebo 0.05 mg/kg
Dosage- 0.05 mg/kg
Drug: Placebo 0.05mg/kg
Placebo Comparator: Placebo 0.15 mg/kg
Dosage - 0.15 mg/kg
Drug: Placebo 0.15mg/kg

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Serum IGF-1 [ Time Frame: Predose, Day 1-Day 28 ]
  2. Serum GH [ Time Frame: Predose, Day 1-Day 28 ]
  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281 [ Time Frame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14 ]
  4. Maximum plasma concentration (Cmax) of ALRN-5281 [ Time Frame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14 ]
  5. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14 ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01775358

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United States, Kansas
Vince and Associates Clinical Research, LLC
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Aileron Therapeutics, Inc.
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Principal Investigator: Bradley D Vince, D.O. Vince and Associates
Study Director: Hubert C Chen, M.D. Aileron Therapeutics, Inc.
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Responsible Party: Aileron Therapeutics, Inc. Identifier: NCT01775358    
Other Study ID Numbers: ALRN-100-01
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013