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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.
 
ClinicalTrials.gov Identifier: NCT01775358
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Aileron Therapeutics

Tracking Information
First Submitted Date  ICMJE January 17, 2013
First Posted Date  ICMJE January 25, 2013
Last Update Posted Date May 30, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
Incidence of adverse events [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
  • Serum IGF-1 [ Time Frame: Predose, Day 1-Day 28 ]
  • Serum GH [ Time Frame: Predose, Day 1-Day 28 ]
  • 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 ]
  • 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 ]
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Safety Study of ALRN-5281 in Healthy Subjects
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: ALRN-5281 0.015 mg/kg
    Dosage-0.015 mg/kg
    Intervention: Drug: ALRN-5281 0.015 mg/kg
  • Experimental: ALRN-5281 0.05 mg/kg
    Dosage- 0.05 mg/kg
    Intervention: Drug: ALRN-5281 0.05 mg/kg
  • Experimental: ALRN-5281 0.15 mg/kg
    Dosage- 0.15 mg/kg
    Intervention: Drug: ALRN-5281 0.15 mg/kg
  • Placebo Comparator: Placebo 0.015 mg/kg
    Dosage- 0.015 mg/kg
    Intervention: Drug: Placebo 0.015 mg/kg
  • Placebo Comparator: Placebo 0.05 mg/kg
    Dosage- 0.05 mg/kg
    Intervention: Drug: Placebo 0.05mg/kg
  • Placebo Comparator: Placebo 0.15 mg/kg
    Dosage - 0.15 mg/kg
    Intervention: Drug: Placebo 0.15mg/kg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2013)
33
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2013)
48
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01775358
Other Study ID Numbers  ICMJE ALRN-100-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aileron Therapeutics
Study Sponsor  ICMJE Aileron Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bradley D Vince, D.O. Vince and Associates
Study Director: Hubert C Chen, M.D. Aileron Therapeutics
PRS Account Aileron Therapeutics
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP